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  • NCS hands over N1.4 B seized expired drugs to NAFDAC

    NCS hands over N1.4 B seized expired drugs to NAFDAC

    Flowerbudnews

    Lagos: The Nigeria Customs Service, Federal Operations Unit (FOU), Zone A, Ikeja, has handed over seized expired drugs, valued at about N1.4 billion to the National Agency for Food and Drug Administration and Control (NAFDAC).

    The FOU Zone A Acting Controller of the Service, DCG Kehinde Ejibunu, did the handing over on Tuesday at the service seized items yard, Ikeja, Lagos.

    Ejibunu said that the drugs were manufactured in India and Malaysia, adding that the warehouse where the goods were seized from was sealed and the owner was still ion the run.

    “The Duty Paid Value is N1.4 billion. The importer would have relabeled the drugs, to sell them to the public.”

    “ As a part of the results achieved from the re~worked strategy; expired, illicit, and other drugs that did not comply with the statutory import requirements were intercepted at different times and locations.

    “ They are constructively warehoused in 39 x 140 ft and 2 x 20 ft containers by this Unit, and will be handed over to NAFDAC,” he said.

    DCG Kehinde Ejibunu of FOU Zone A Ikeja presenting seized drugs to NAFDAC officials on Tuesday in Lagos

    Receiving the drugs, the NAFDAC Director of Investigation, Mr Francis Onaniwu, commended the NCS for saving members of the public from more health challenges , which the expired drugs would have caused should they be used.

    He said that the drugs expired in November 2021, stressing that the agency would investigate and analyse the drugs, to ascertain their potencies.

    Onaniwu added that the agency was already investigating a case relating to similar drugs, stressing that one of the findings was to ascertain if the importer is same with the one they were investigating.

    The director noted that the importer smuggled the drugs into the country because he knew if presented to the agency, they will not pass the laboratory tests.

    Onaniwu said that the agency had dealt with such drugs and importers in the past.

    He explained that the Controller of NCS handed over expired drugs, which was in large quantities, to NAFDAC.

    “This is huge. Imagine if this quantity of drugs that are in these containers get to members of the public.

    “The drugs , one is not sure of the quality, because from the one I am holding in my hand, the drug already expired in November 2021 and we know the implications of expired drugs.

    “We are sure that if they have not been confiscated by NCS, definitely, if they enter circulation, the importers will not want to lose their investment.

    “He will change the expired date to new date and relabel the drugs. People consuming such would have consumed poison,” he said. (NAN) www.nannews.ng / Flowerbudnews

  • NAFDAC warns against use of unapproved cosmetics

    NAFDAC warns against use of unapproved cosmetics

    Flowerbudnews

     

    Isaiah Eka/Nathan Nwakamma

    Port Harcourt:  The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians not to use unapproved cosmetics because the dangers were largely irreversible.

     

    The Director-General NAFDAC, Prof. Mojisola Adeyeye, gave the warning during the media sensitisation workshop on dangers of bleaching creams and regulatory controls for South South Journalists in Port Harcourt on Tuesday.

     

    Adeyeye, who was represented by Dr. Leonard Omokpariola, Director, Drug Evaluation and Research, said the menace of unapproved cosmetics such as bleaching creams in Nigeria had become a national health emergency that required multi-faced regulatory approach.

    According to the NAFDAC D-G, the unapproved cosmetics used banned and toxic chemicals to achieve skin lightening effects that leaves the user with undesirable effects.

     

    She listed some of the harmful effects of bleaching creams to include cancer, damage to vital organs of the body like kidney and liver.

    It also causes skin cancer, irritation and allergy, skin burn and rashes, wrinkles, premature skin ageing and prolonged healing of wounds.

    The DG said that the World Health Organisation in a 2018 study, revealed that use of skin bleaching creams was prevalent among 77 per cent of Nigerian women which was highest in Africa, compared to 59 per cent in Togo, 35 per cent in South Africa and 27 per cent women in Senegal.

     

    She said that the essence of the sensitisation workshop was to train Journalists and stakeholders, who will inform the public on the dangers of those cosmetics.

     

    Adeyeye added that the sensitisation workshop was a Train the Trainers’ programme with the great expectation that participants would assume role of champions in the campaign against use of bleaching creams in the country.

     

    She added that after the sensitisation campaign, the agency would take stringent regulatory actions to stem the dangerous tide of rampant and pervasive cases of Nigerians using bleaching creams.

    The director general thanked journalists and stakeholders for their collaboration and support for NAFDAC to rid the country of the menace of substandard and falsified medicines, unwholesome foods, corrosive cosmetics and other substandard regulated products.

     

    Representatives of Pharmaceutical Society of Nigeria, cosmetics manufacturers, supermarket operators, Nigerian Customs Health officials, amongst other stakeholders attended the workshop.

     

    Earlier, Dr Abubakar Jimoh, NAFDAC Director of Public Affairs, said the war against menace of bleaching cream across the country was sequel to a resolution of the 2022 Senate, promoted by Sen Oluremi Tinubu.

    According to Jimoh, the Senate resolution crystallised to a memorandum from the Secretary to Government of the Federation directing NAFDAC to strengthen its regulatory functions to curb the menace. (NAN) (www.nannews.ng)/Flowerbudnews

  • NAFDAC Intensifies Support for NMSMEs to Boost Economy,  Offers Product Renewal Waiver

    NAFDAC Intensifies Support for NMSMEs to Boost Economy,  Offers Product Renewal Waiver

    Flowerbudnews

     

    By Biola Lawal
    Abuja: (Flowerbudnews): The Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof Moji Adeyeye has assured operators of Nano Micro, Small and Medium Enterprises NMSMEs of NAFDAC commitment to help them grow.

    Prof Adeyeye noted that NAFDAC assistance would enable the Small Scale enterprises act as catalyst for the nations economic transformation.

    The Director General gave the assurance at a recent meeting organized by the Lagos State Office of the Agency with operators of NMSMEs in the nations commercial capital.

    Prof. Adeyeye said that  NAFDAC would continue to drive collaboration and understanding with the NMSMEs  to empower them in terms of the next step for their businesses.

    We remain committed to meeting the yearnings and aspirations of the business community, she said, adding that the gains and positive impact of subjecting their processes and products to regulatory scrutiny are immense.

    According to the DG, such regulatory scrutiny is also meant to protect their businesses.When I see you, I see myself because I was raised up trading with my mother, with my grandmother selling things.

    I know how hard it is to put money together and trade. I know how hard it is or the anxious moments that the average trader has, wondering whether he or she is going to have profit, she empathized with the small business owners.

    In a statement by Resident Media Consultant to NAFDAC, Sayo Akintola, in Lagos on Monday, Prof Adeyeye noted that  the NMSMEs drive the economy of Nigeria, noting that Nigeria had a recession few years ago and came out of it quickly despite the challenges of the mega industry.

    How did we come out of it quickly?’’, she asked rhetorically, as she swiftly responded by saying that the NMSMEs sub-sector was the magic wand that sustained the economy during the turbulent times.

    However, because of our mandate, food, packaged water, and cosmetics. Three of our mandate are under NMSMEs, even some chemicals, some herbals.

    Therefore, we do not take NMSMEs matter lightly’, she said. She added that operators of NMSMEs should always focus on one product that is well accepted by the consumers rather than manufacturing many products at the same time whereby none would be doing well in the market.

    Dont make five products at a time please. You can try it and the one that is fast you can focus on that and make it great,’’ she said, as she admonished NMSME operators to dream big by entering the global market with their products.

    She emphasized the commercial benefits and opportunities that abound for products that have been subjected to regulatory scrutiny, describing them as immense. One of such is the possibility of exporting such goods.

    With exportation comes quality. Without being quality-conscious, exported products will be rejected. We are here to work with you to take your trading to the level that you want. I want us to also think not of just what we consume here but what we can export’.

    The NAFDAC boss, however, disclosed that the Agency is already talking with the United Kingdom Department of Business and Trade to build a bilateral relationship whereby Nigerian products that are exported to the United Kingdom will be of quality, (having been registered and certified by NAFDAC).

    She regretted the incidence of rejected food exports from Nigeria at the point of entry due to bad quality, stressing that if such food items were subjected to NAFDAC scrutiny, the incidents of rejected food exports from Nigeria would have been greatly curtailed.

    Please lets think of the future or where we can take our products to, she said, adding that Nigerians abroad are concerned about what we are doing in terms of food that they cannot live without overseas.

    Some of our people cannot live without eating Eba, (Cassava flour) Pounded yam or Amala (Yam flour). Some people cannot cook without palm oil. There are a lot of opportunities for us to tap into, she further admonished them.

    Despite the fact that NMSMEs trading is not a mega industry, Prof. Adeyeye insisted that we still have to do the testing to make sure that whatever is put out there first, is not going to harm whoever is taking it. And its also going to last long enough on the shelf. Thats where the quality aspect comes in.

    The NAFDAC DG assured the business owners of the continued support of the Agency, emphasizing that the staff of the Agency are being trained not to compromise, and to hold customers with high esteem based on quality management system.

    She however, assured business owners who are desirous of entering the marketplace with NAFDAC regulated products of maximum support, saying we will provide you with the necessary guidance, and support.

    The Lagos State Office led by Dr Monica Eimunjeze put together some informative presentations for the entrepreneurs benefits which demonstrated what exists as well as NAFDAC regulatory expectations across board. (Flowerbudnews)

  • NAFDAC seals 2 shops in Abuja for allegedly selling unregistered aphrodisiacs

    NAFDAC seals 2 shops in Abuja for allegedly selling unregistered aphrodisiacs

    Flowerbudnews

     

    By Aderogba George

    Abuja: The National Agency for Food and Drug Administration and Control (NAFDAC) on Wednesday in Abuja sealed two shops for allegedly selling unapproved products to Nigerians.

    The shops are located in the Zuba Central motor park and Utako main market.

    The News Agency of Nigeria (NAN) reports that some of the unregistered products said to be aphrodisiacs are: “Hajiya Ayesha Snuff, AK47, Bulletproof and Hajiya Aysha Maisanda”.

    Mr Tamanuwa Baba, Deputy Director, investigation and Enforcement directorate, NAFDAC, said the operation followed intelligence reports received about the shops.

    “The products are meant to boost sexual performance and some were said to have been manufactured in Ghana.

    “NAFDAC laboratory analysis indicates that these products contain a chemical substance called Pyridine which is a potentially harmful to the human body.

    “We found a lot of unregistered products in the two shops. We will begin immediate investigations ,” he said.

     

    Baba said that the agency has apprehended the sales representative in the Zuba shop pending when the owner of the shop will return from his journey.

    “We will get in touch with the owner of the shop on where he is sourcing these products from, but from the label on the products, some of them were allegedly manufactured in Ghana.

    “What the sellers are saying is that these products usually make them high and some said that the product is used as an aphrodisiac.

    “After the investigation, these products are going to be destroyed because they have not been registered by us.

    He said similar set of products were also discovered in a shop at Utako known as Kabo Investment Limited.

    He said that it was scary that  some of the products have flooded the Nigerian market and that they are fast spreading because the agency conducted a similar operation in Sokoto where some of the products were removed from a shop.

    “I can tell you that  Pyridine which is the chemical that is contained in some of these products can cause cancer, skin irritation and even lead to death. (NAN) (www.nannews.ng/ Flowerbudnews

  • NAFDAC approves R21 malaria vaccine

    NAFDAC approves R21 malaria vaccine

    By Aderogba George

    The National Agency for Food and Drug Administration and Control
    (NAFDAC) said it has granted approval to Serum Institute Pvt. Ltd. (SIIPL) R21 malaria vaccine for the treatment of malaria in Nigeria.

    The Director-General, Prof. Mojisola Adeyeye, said this at a news conference on Monday in Abuja.

    She said that the granting of registration/approval was in line with the agency’s mandate as stipulated
    by its enabling law — NAFDAC Act CapN1, Law of the Federation of Nigeria (LFN) 2004.

    Adeyeye said that it became necessary to grant approval for the vaccine following the 2021 World Malaria Report that Nigeria had the highest number of global malaria cases of 27 per cent.

    She said the highest number of deaths stood at 32 per cent of global malaria deaths in 2020, adding that Nigeria
    accounted for an estimated 55.2 per cent of malaria cases in West Africa in 2020.

    “Malaria is one of the most important public health concerns in the world, the latest World Health Organisation (WHO)
    Malaria Report shows there were 247 million cases of malaria in 2021 compared to 245 million cases in 2020.’’

    She explained that the estimated number of malaria deaths stood at 619000 in 2021 compared to 625000 in 2020.

    “Over the two peak years of the pandemic (2020–2021), COVID-related disruptions led to about 13 million more malaria
    cases and 63000 more malaria deaths.

    “The WHO African Region continues to carry a disproportionately high share of the global malaria burden. In 2021 the
    region was home to about 95 per cent of all malaria cases and 96 per cent of deaths.

    “Children under five years of age accounted for about 80 per cent of all malaria deaths in the region. Four African countries
    accounted for just over half of all malaria deaths worldwide, with Nigeria; 31.3 per cent, the Democratic Republic of the Congo;
    12.6 per cent, United Republic of Tanzania; 4.1 per cent and Niger; 3.9 per cent respectively.

    “Malaria is transmitted throughout Nigeria, with 97 per cent of the population at risk. The duration of the transmission
    season ranges from year-round transmission in the south to three months or less in the north,’’ she stressed.

    She said that the Marketing Authorisation Holder’s (MAHs) for the vaccine is Fidson Healthcare Ltd,
    which had the agency’s Drug and Related Products Registration Regulation 2021.

    According to Adeyeye, the R21 malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution.

    She explained that “a dose, which is 0.5ml, is composed of R21 Malaria antigen 5µg and Matrix-M1 50µg as an
    adjuvant filled in a vial as ready to use liquid formulation for intramuscular injection.’’

    She said that the vaccine is indicated for prevention of clinical malaria in children from five months to 36 months
    of age, adding that the storage temperature of the vaccine is 2-8 °C.

    The NAFDAC boss said the agency had several pathways for registration of vaccines, in line with the agency’s guideline for registration of Imported Drugs, Vaccines and IVDs under Collaborative Registration Procedure.

    Adeyeye said the agency received the dossier of the R21 Malaria manufactured by SIIPL and subjected it to independent review at two different levels.

    She added that as a matured regulatory agency, it is expected as part of global benchmarking that external advisory
    committee was put in place to give advise upon invitation on certain functions of the agency.

    She said that as a new biological molecule being given consideration for full registration, the independent review
    by an external body became imperative to further safeguard public health.

    The external advisory body known as NAFDAC’s Vaccine Advisory Committee (NEVAC) is made up of four highly
    recognised, well-published experts from Nigeria’s tertiary institutions, she said.

    She listed the institutions where the advisory body members were selected as Nnamdi Azikwe University, Awka,
    Anambra State; University of Lagos, Lagos State, University of Ibadan, Oyo State and Usman Dan Fodio University, Sokoto, Sokoto State.

    Adeyeye said that the agency also had in-house Vaccine Review Committee (NEVAC) extracted from different directorates of NAFDAC to oversee, evaluate, as well as carry out clinical trials on vaccine before approval was made.

    She said that the dossier was reviewed using WHO standard across relevant domains, in addition to the European Medicines Agency guidelines (where appropriate), scientific rigor on the vaccine.

    According to her, the review of NAFDAC’s committee has always been guided by the same international standards and best practices with the same modality of independent review by members.

    “This is followed by long hours of plenary where rigorous assessment of each review took place.’’

    She said that the committee also independently scored the assessment as satisfactory, which was then
    forwarded to the director-general and that upon submission of the reviews of both committees, the NAFDAC boss
    called for a joint review session on April 14.

    Adeyeye said that the joint review process provided the opportunity to harmonise the assessments, the outcomes of the reviews were discussed, and the recommendations and queries/clarifications were consolidated to be referred to the
    manufacturers.

    She said that the R21 Malaria Vaccine dossier complied substantially with best international standards with which
    the dossier was benched-marked.

    She added that the Joint Review Committee concluded that the data on the R21 malaria vaccine were robust
    and met criteria for efficacy, safety and quality.

    NAN

  • NAFDAC pledges to support NMSMEs for economic growth

    NAFDAC pledges to support NMSMEs for economic growth

    Flowerbudnews

     

    By Aderogba George

    Abuja:.  The National Agency for Food and Drug Administration and Control (NAFDAC) has pledged to support the Nano Micro, Small and Medium Enterprises (NMSMEs) to enable them to grow the nation’s economy.

    A statement by NAFDAC Resident Media Consultant, Mr Olusayo Akintola, on Tuesday stated that the agency’s Director-General, Prof Mojisola Adeyeye, made the disclosure at a meeting in Lagos.

    According to the director-general, NAFDAC will continue to drive collaboration and understanding between NMSMEs and the regulatory authority with a view to empowering them in terms of the next step for their businesses.

    Adeyeye said that NAFDAC remained committed to meeting the yearnings and aspirations of the business community, adding that the gains and impact of subjecting products and services to regulatory scrutiny were vital.

    The director-general said that such regulatory scrutiny was all about protecting businesses and their environment.

    “When I see you, I see myself because I was raised up trading with my mother, with my grandmother selling things. I know how hard it is to put money together and trade.

    “I know how hard it is or the anxious moments that the average trader has, wondering whether he or she is going to have profit,” she.

    She said that NMSMEs was capable of driving the economy of Nigeria, adding that Nigeria had a recession a few years ago and still came out of it despite all the odds and the challenges of the mega industry.

    “How did we come out of it quickly?’’ asking rhetorically, as she said that NMSMEs subsector was the magic wand that sustained the economy during the turbulent period.

    She said that this was possible because of the mandate from the agency on food, packaged water, cosmetics and others.

    Adeyeye said that three of the agency’s mandates were under NMSMEs, along with chemical and herbal regulations.

    She said that the agency would not take NMSMEs matter lightly.

    She urged operators of NMSMEs to always focus on one product that is well accepted by the consumers rather than manufacturing many products at the same time where none would be accepted.

    The NAFDAC boss admonished NMSMEs operators to dream big by entering the global market with their products, adding that commercial opportunities and benefits were abound for products that had been subjected to regulatory scrutiny.

    According to her, one of such opportunities is the possibility of exporting such goods, noting that exportation is tied to quality.

    Adeyeye said that NAFDAC was on ground to work with NMSMEs to take its trading to a higher level, adding that they must not only think of what to consume but what could be exported.

    Adeyeye said that the agency was already talking with the UK Department of Business and Trade to build a bilateral relations in which Nigerian products that are exported to that country would be of high quality having been registered with NAFDAC.

    She expressed regrets at the incidence of rejected food exports from Nigeria at the point of entry due to bad quality.

    She said that if such food items had been subjected to NAFDAC scrutiny, the incidence of rejection would have been curtailed.

    “Let us think of the future or where we can take our products to, Nigerians abroad are concerned about what we are doing in terms of foods that we are exporting.

    “Some of our people cannot live without eating eba, (cassava flour), pounded yam or amala (yam flour). Some people cannot cook without palm oil. There are a lot of opportunities for us to tap into,” she said.

    She insisted that the agency must continue to do testing of foods and others things to make sure that whatever was put out there first was not going to be harmful.

    The director-general assured NMSME of NAFDAC’s continued support of NAFDAC, emphasizing that staff of the agency were being trained not to compromise and to hold customers with high esteem based on quality management system.

    She equally assured business owners who are desirous of entering the marketplace with NAFDAC regulated products of maximum support, saying the agency would provide them with necessary guidance and support. (NAN) (www.nannews.ng)

  • NAFDAC Boss Warns Nigerians Against Use of Suspected Deadly Cough Syrup – NATURCOLD

    NAFDAC Boss Warns Nigerians Against Use of Suspected Deadly Cough Syrup – NATURCOLD

    By Biola Lawal

    Abuja: (Flowerbudnews) The Director-General of the National Agency for Food and Drugs Administration and Control (NAFDAC), Prof Moji Adeyeye has warned Nigerians against use of a suspected cough syrup, NATURCOLD said to have caused death of six children in Cameroon.

    Prof. Adeyeye gave the warning in a NAFDAC public alert entitled: Alert on Killer Cough Syrup Manufactured by Fraken in Cameroon, detailing dangers of the suspected substandard drug as made available by the Cameroonian Ministry of Health.

    The NAFDAC Boss disclosed that the suspected substandard product, which is said to be manufactured by Fraken Group was believed to have caused the deaths of six children under the age of five at a health facility in the health district of Fundong in North-West region of Cameroon.

    Prof. Adeyeye said: The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public that the Ministry of Public Health in Cameroon has issued an alert regarding a suspected substandard cough syrup named NATURCOLD .

    According to the North-West Regional of Cameroon delegate for Public Health, the children showed a decrease in kidney function after consuming the suspected substandard cough syrup.

    The product is not authorized for marketing in Cameroon and was purchased from unauthorized sources.

    The NAFDAC Boss stated that ‘although the product is not in NAFDAC database, importers, distributors, retailers, and consumers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard (contaminated) syrups.

    Prof Adeyeye urged that all medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

    The NAFDAC Boss implored members of the public to desist from purchasing medicinal products from unauthorized sources such as roadside vendors and street hawkers as fake drugs are mostly smuggled into the country from neighbouring countries and distributed through such inappropriate channels,

    She advised further that ”anyone in possession of the above-mentioned product is advised to discontinue sale or use and submit stock to the nearest NAFDAC office.

    ” If you, or someone you know, have used these products, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.

    Prof Adeyeye also urged Healthcare professionals and consumers are advised to report any suspicion of sale and use of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng

    She also advised: ‘:healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng   (Flowerbudnews)

  • NAFDAC approves R21 malaria vaccine

    NAFDAC approves R21 malaria vaccine

    Flowerbudnews

    By Aderogba George
    Abuja: The National Agency for Food and Drug Administration and Control (NAFDAC) said it has granted approval to Serum Institute Pvt. Ltd. (SIIPL) R21 malaria vaccine for
    the treatment of malaria in Nigeria.

    The Director-General, Prof. Mojisola Adeyeye, said this at a news conference on Monday in Abuja.

    She said that the granting of registration/approval was in line with the agency’s mandate as stipulated
    by its enabling law — NAFDAC Act CapN1, Law of the Federation of Nigeria (LFN) 2004.

    Adeyeye said that it became necessary to grant approval for the vaccine following the 2021 World Malaria Report that Nigeria had the highest number of global malaria cases of 27 per cent.

    She said the highest number of deaths stood at 32 per cent of global malaria deaths in 2020, adding that Nigeria accounted for an estimated 55.2 per cent of malaria cases in West Africa in 2020.

    “Malaria is one of the most important public health concerns in the world, the latest World Health Organisation (WHO)
    Malaria Report shows there were 247 million cases of malaria in 2021 compared to 245 million cases in 2020.’’

    She explained that the estimated number of malaria deaths stood at 619000 in 2021 compared to 625000 in 2020.

    “Over the two peak years of the pandemic (2020–2021), COVID-related disruptions led to about 13 million more malaria
    cases and 63000 more malaria deaths.

    “The WHO African Region continues to carry a disproportionately high share of the global malaria burden. In 2021 the
    region was home to about 95 per cent of all malaria cases and 96 per cent of deaths.

    “Children under five years of age accounted for about 80 per cent of all malaria deaths in the region. Four African countries
    accounted for just over half of all malaria deaths worldwide, with Nigeria; 31.3 per cent, the Democratic Republic of the Congo;
    12.6 per cent, United Republic of Tanzania; 4.1 per cent and Niger; 3.9 per cent respectively.

    “Malaria is transmitted throughout Nigeria, with 97 per cent of the population at risk. The duration of the transmission
    season ranges from year-round transmission in the south to three months or less in the north,’’ she stressed.

    She said that the Marketing Authorisation Holder’s (MAHs) for the vaccine is Fidson Healthcare Ltd,
    which had the agency’s Drug and Related Products Registration Regulation 2021.

    According to Adeyeye, the R21 malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution.

    She explained that “a dose, which is 0.5ml, is composed of R21 Malaria antigen 5µg and Matrix-M1 50µg as an
    adjuvant filled in a vial as ready to use liquid formulation for intramuscular injection.’’

    She said that the vaccine is indicated for prevention of clinical malaria in children from five months to 36 months
    of age, adding that the storage temperature of the vaccine is 2-8 °C.

    The NAFDAC boss said the agency had several pathways for registration of vaccines, in line with the agency’s guideline
    for registration of Imported Drugs, Vaccines and IVDs under Collaborative Registration Procedure.

    Adeyeye said the agency received the dossier of the R21 Malaria manufactured by SIIPL and subjected it
    to independent review at two different levels.

    She added that as a matured regulatory agency, it is expected as part of global benchmarking that external advisory
    committee was put in place to give advise upon invitation on certain functions of the agency.

    She said that as a new biological molecule being given consideration for full registration, the independent review
    by an external body became imperative to further safeguard public health.

    The external advisory body known as NAFDAC’s Vaccine Advisory Committee (NEVAC) is made up of four highly
    recognised, well-published experts from Nigeria’s tertiary institutions, she said.

    She listed the institutions where the advisory body members were selected as Nnamdi Azikwe University, Awka, Anambra State; University of Lagos, Lagos State, University of Ibadan, Oyo State and Usman Dan Fodio University, Sokoto, Sokoto State.

    Adeyeye said that the agency also had in-house Vaccine Review Committee (NEVAC) extracted from different directorates of NAFDAC
    to oversee, evaluate, as well as carry out clinical trials on vaccine before approval was made.

    She said that the dossier was reviewed using WHO standard across relevant domains, in addition to the European Medicines
    Agency guidelines (where appropriate), scientific rigor on the vaccine.

    According to her, the review of NAFDAC’s committee has always been guided by the same international standards and best
    practices with the same modality of independent review by members.

    “This is followed by long hours of plenary where rigorous assessment of each review took place.’’

    She said that the committee also independently scored the assessment as satisfactory, which was then forwarded to the director-general and that upon submission of the reviews of both committees, the NAFDAC boss called for a joint review session on April 14.

    Adeyeye said that the joint review process provided the opportunity to harmonise the assessments, the outcomes of the reviews were discussed, and the recommendations and queries/clarifications were consolidated to be referred to the
    manufacturers.

    She said that the R21 Malaria Vaccine dossier complied substantially with best international standards with which the dossier was benched-marked.

    She added that the Joint Review Committee concluded that the data on the R21 malaria vaccine were robust and met criteria for efficacy, safety and quality. (NAN)(www.nannews.ng)/Flowerbudnews

     

  • Nigerian Indomie Noodles safe to consume ? NAFDAC

    Nigerian Indomie Noodles safe to consume ? NAFDAC

    The National Agency for Food and Drug Administration and Control (NAFDAC) said on Tuesday that Noodles made in Nigeria have nothing to do with the noodles produced in Taiwan and Malaysia. The regulator also said that noodles made in Nigeria are safe for consumption.

    Speaking as a guest on a popular TV show, Your View, aired on TVC television, Director-General, NAFDAC, Mojisola Adeyeye, further added that “foreign noodles have been banned from entering the country by the Nigerian government many years ago and this is on the Nigerian Customs Service importation prohibition list and this is to encourage local production of noodles and backward integration of the economy.”

    NAFDAC also said it is working to ensure that foreign-made noodles are not smuggled into the country. NAFDAC Food Safety and Applied Nutrition (FSAN) organisation, has commenced post-marketing surveillance (PMS) and the Food Lab Services Directorate has also been activated on the issue.

     

    According to the Group Corporate Communications and Event Manager, Dufil Prima Foods Plc, Tope Ashiwaju, said “Indomie Nigeria is different and a separate entity from Indomie Taiwan, and Indomie Malaysia. Indomie instant Noodles is locally produced in the country and operations have been ongoing for at least three decades. Dufil Prima has improved local capacity utilisation and has aided enhanced production to meet market demand, rather than depending on importation.”

    Nigeria is a major consumer of instant noodles, with Indomie Instant Noodles dominating the market. The World Instant Noodles Association (WINA) said Nigeria is one of the largest consumers of instant noodles, with 1.92 million. The ban on the importation of instant noodles is not a recent development, as instant noodles have been on the importation prohibition list of the Federal Government for a long time.