What are the workings of NAFDAC since its inception in 1999. What are the specific mandates of NAFDAC?
What are some of the common challenges your organization faces especially during implementation, inspection or supervision?
Are there any new innovations or trajectory we should be expecting from NAFDAC?
The National Agency for Food and Drug Administration and Control (NAFDAC) was established by Decree 15 of 1993 and amended by Decree 19 of 1999. It is now cited as National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria 2004.
NAFDAC was officially established in October 1992 to promptly address the challenges of rising incidence of counterfeit and substandard drugs, unwholesome food and other regulated products as well as to overcome the bureaucratic bottlenecks in the Federal Ministry of Health.
The vision of the Agency is to safeguard public health while the mission is to safeguard public health by ensuring that only the right quality drugs, food and other regulated products are manufactured, imported, exported, advertised, distributed, sold and used in Nigeria.
The pioneer Director General was Prof. Gabriel Ediale Osuide who held office from 1993 to year 2000 when he was removed and an Interim Management Committee was set up to oversee activities of the Agency. In 2001, Late Prof. Dora Akunyili (OFR) was appointed the Director General. In 2009, Dr Paul Orhii (OON) became the Director General and in 2017, the current Director General, Prof Mojisola Christianah Adeyeye took over.
Over the years, NAFDAC has greatly evolved in her structure and quality of services rendered to the public. At inception, the Agency had 9 Departments which became 12 and now there are 18 Directorates with 8 zonal Offices (6 geopolitical zones, FCT and Lagos State Office). There are also offices in the 36 states of the Federation and 7 Quality Control laboratories around the country.
The Agency is now customer-focused and Agency-minded which means our customers or clients are better served while still maintaining our core values and carrying out our mandates effectively. Most of our processes are now digitalized including registration process. The Agency has now been certified as ISO 9001:2015 quality management system or establishment and is in process of being listed as a WHO Listed Authority (WLA) using the Global Bench Marking Tool (GBT).
The specific mandate of NAFDAC is to regulate and control the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, packaged water, chemicals and detergents.
What are the standard procedures to get NAFDAC registration and certification for SMEs
Tell us about the various category of registration especially as it concerns small businesses or small scale manufacturers
The procedure for registration is as follows:
• Online submission of documents including application through the NAFDAC Automated Products Administration and Monitoring System (NAPAMS) Portal
• Vetting of documents and issuance of compliance directives if there are issues with the documents submitted
• Scheduling for inspection of facility or factory
• Carrying out facility inspection
• Sampling of products for laboratory analysis if report of inspection is satisfactory. If inspection is not satisfactory, non-conformance observation letter is issued to company to address all the observed non-conformances or lapses. After correction, a follow-up inspection is carried out. If satisfactory, samples of products are now taken for analysis.
• If laboratory analysis is satisfactory, the products are recommended for registration either on listing basis or for full registration.
• The products are presented at the Food, Drug Registration Committee (FDRC) meeting for approval after other processes have been carried out.
• Upon approval of the Committee, NAFDAC Registration Numbers are assigned to the products.
There are 2 types of registration:
• Listing License for 2 years and is renewable
• Full Registration for 5 years and is renewable
Most Micro and Small Enterprises get the Listing License because of the facilities and equipment they have.
NAFDAC is encouraging small businesses in the following ways:
• Decentralization of registration. Prior to 2018, all registrations were done in Lagos. However, having recognized the importance of Micro Enterprises, the Agency decentralized registration of their products and is now done on zonal basis including FCT office.
• Companies manufacturing similar products can use one facility, that is shared facility to reduce cost of setting up factory.
• Timeline for registration of their products has been reduced to between 60 and 90 working days.
• The facility requirement has been reduced from 4 rooms to one standard room and a store
• The number of products that are being registered on a zonal basis has been increased from 11 to over 80 different products.
• Guidelines and documentation requirements have been streamlined to make it easier for micro and small industries to register their products
In 2020, from May 15 to November 14, the Agency gave palliative to micro and small industries in the following ways in order to cushion effect of the pandemic:
• Reducing cost of registration by 80% (for micro =N7, 595 from N36,737.50 for food while cosmetics was reduced to N8,455 from N41,000.00 and for small business N13, 400 from N67,000 for food and N21,140 from N105,700 for cosmetics.
• Free registration for the first 200 companies that submitted application.
• No payment of late renewal fees for 3 months for companies that had expired licenses. What are the other services and or products your org has beyond registration or certification of products
Has covid19 affected the workings of NAFDAC in anyway?
The other services rendered by NAFDAC apart from Product Registration are numerous and include the following:
• Laboratory evaluation
• Inspection of factories in Nigeria for different reasons-special visit (Initial/advisory); routine inspection, follow-up; GMP reassessment, production, pre-registration and registration.
• Inspection of foreign companies before registration of imported products
• Investigation and enforcement activities
• Inspections at the Ports-airport and seaports both for import and export of regulated products
• Control of exportation of regulated products especially food and medical products, and issuance of quality certificates for intended products for export
• Take measures to ensure that narcotic drugs and psychotropic substances are limited to only medical and scientific purposes by issuing permits to import and clear these substances as well as other controlled substances
• Carry out Drug Demand Reduction activities such as organizing Drug abuse lectures in schools, motor parks etc.
• Collaborate with NDLEA to eradicate drug abuse
• Control chemicals, agrochemicals etc by issuing permits to import and clear as well as monitor their distribution, sale and use
• Pharmacovigilance – safety monitoring of drugs (including vaccines), cosmetics and medical devices
• Post Marketing Surveillance – to eradicate substandard and falsified medicines, and unwholesome foods
• Carry out surveys on different regulated products
• Issue permits for Global Listing of Supermarket Items
• Collaborate with other regulatory agencies, regionally, continentally and globally
• Numerous other activities
Yes. Covid has affected our operations in NAFDAC:
• Inspections are now both virtual and physical
• Most meetings (with staff and stakeholders) are now virtual
• Document submissions are mostly electronic now which has reduced physical visits to the office by clients
• In summary, most of our processes have been digitalized.
What are some of the common challenges your organization faces especially during implementation, inspection or supervision?
Are there any new innovations or trajectory we should be expecting from NAFDAC?
What are the workings of NAFDAC since its inception in 1999. What are the specific mandates of NAFDAC?
ANSWERS
The National Agency for Food and Drug Administration and Control (NAFDAC) was established by Decree 15 of 1993 and amended by Decree 19 of 1999. It is now cited as National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria 2004.
NAFDAC was officially established in October 1992 to promptly address the challenges of rising incidence of counterfeit and substandard drugs, unwholesome food and other regulated products as well as to overcome the bureaucratic bottlenecks in the Federal Ministry of Health.
The vision of the Agency is to safeguard public health while the mission is to safeguard public health by ensuring that only the right quality drugs, food and other regulated products are manufactured, imported, exported, advertised, distributed, sold and used in Nigeria.
The pioneer Director General was Prof. Gabriel Ediale Osuide who held office from 1993 to year 2000 when he was removed and an Interim Management Committee was set up to oversee activities of the Agency. In 2001, Late Prof. Dora Akunyili (OFR) was appointed the Director General. In 2009, Dr Paul Orhii (OON) became the Director General and in 2017, the current Director General, Prof Mojisola Christianah Adeyeye took over.
Over the years, NAFDAC has greatly evolved in her structure and quality of services rendered to the public. At inception, the Agency had 9 Departments which became 12 and now there are 18 Directorates with 8 zonal Offices (6 geopolitical zones, FCT and Lagos State Office). There are also offices in the 36 states of the Federation and 7 Quality Control laboratories around the country.
The Agency is now customer-focused and Agency-minded which means our customers or clients are better served while still maintaining our core values and carrying out our mandates effectively. Most of our processes are now digitalized including registration process. The Agency has now been certified as ISO 9001:2015 quality management system or establishment and is in process of being listed as a WHO Listed Authority (WLA) using the Global Bench Marking Tool (GBT).
The specific mandate of NAFDAC is to regulate and control the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, packaged water, chemicals and detergents.
What are the standard procedures to get NAFDAC registration and certification for SMEs
Tell us about the various category of registration especially as it concerns small businesses or small scale manufacturers
The procedure for registration is as follows:
• Online submission of documents including application through the NAFDAC Automated Products Administration and Monitoring System (NAPAMS) Portal
• Vetting of documents and issuance of compliance directives if there are issues with the documents submitted
• Scheduling for inspection of facility or factory
• Carrying out facility inspection
• Sampling of products for laboratory analysis if report of inspection is satisfactory. If inspection is not satisfactory, non-conformance observation letter is issued to company to address all the observed non-conformances or lapses. After correction, a follow-up inspection is carried out. If satisfactory, samples of products are now taken for analysis.
• If laboratory analysis is satisfactory, the products are recommended for registration either on listing basis or for full registration.
• The products are presented at the Food, Drug Registration Committee (FDRC) meeting for approval after other processes have been carried out.
• Upon approval of the Committee, NAFDAC Registration Numbers are assigned to the products.
There are 2 types of registration:
• Listing License for 2 years and is renewable
• Full Registration for 5 years and is renewable
Most Micro and Small Enterprises get the Listing License because of the facilities and equipment they have.
NAFDAC is encouraging small businesses in the following ways:
• Decentralization of registration. Prior to 2018, all registrations were done in Lagos. However, having recognized the importance of Micro Enterprises, the Agency decentralized registration of their products and is now done on zonal basis including FCT office.
• Companies manufacturing similar products can use one facility, that is shared facility to reduce cost of setting up factory.
• Timeline for registration of their products has been reduced to between 60 and 90 working days.
• The facility requirement has been reduced from 4 rooms to one standard room and a store
• The number of products that are being registered on a zonal basis has been increased from 11 to over 80 different products.
• Guidelines and documentation requirements have been streamlined to make it easier for micro and small industries to register their products
In 2020, from May 15 to November 14, the Agency gave palliative to micro and small industries in the following ways in order to cushion effect of the pandemic:
• Reducing cost of registration by 80% (for micro =N7, 595 from N36,737.50 for food while cosmetics was reduced to N8,455 from N41,000.00 and for small business N13, 400 from N67,000 for food and N21,140 from N105,700 for cosmetics.
• Free registration for the first 200 companies that submitted application.
• No payment of late renewal fees for 3 months for companies that had expired licenses. What are the other services and or products your org has beyond registration or certification of products
Has covid19 affected the workings of NAFDAC in anyway?
The other services rendered by NAFDAC apart from Product Registration are numerous and include the following:
• Laboratory evaluation
• Inspection of factories in Nigeria for different reasons-special visit (Initial/advisory); routine inspection, follow-up; GMP reassessment, production, pre-registration andregistration.
• Inspection of foreign companies before registration of imported products
• Investigation and enforcement activities
• Inspections at the Ports-airport and seaports both for import and export of regulated products
• Control of exportation of regulated products especially food and medical products, and issuance of quality certificates for intended products for export
• Take measures to ensure that narcotic drugs and psychotropic substances are limited to only medical and scientific purposes by issuing permits to import and clear these substances as well as other controlled substances
• Carry out Drug Demand Reduction activities such as organizing Drug abuse lectures in schools, motor parks etc.
• Collaborate with NDLEA to eradicate drug abuse
• Control chemicals, agrochemicals etc by issuing permits to import and clear as well as monitor their distribution, sale and use
• Pharmacovigilance – safety monitoring of drugs (including vaccines), cosmetics and medical devices
• Post Marketing Surveillance – to eradicate substandard and falsified medicines, and unwholesome foods
• Carry out surveys on different regulated products
• Issue permits for Global Listing of Supermarket Items
• Collaborate with other regulatory agencies, regionally, continentally and globally
• Numerous other activities
Yes. Covid has affected our operations in NAFDAC:
• Inspections are now both virtual and physical
• Most meetings (with staff and stakeholders) are now virtual
• Document submissions are mostly electronic now which has reduced physical visits to the office by clients
• In summary, most of our processes have been digitalized.
What are some of the common challenges your organization faces especially during implementation, inspection or supervision?
Are there any new innovations or trajectory we should be expecting from NAFDAC?
Some of the challenges we face include but not limited to the following:
• Shortage of staff
• Inadequate renumeration
• Inadequate working tools-vehicles, computers and accessories, laboratory equipment, poor network connectivity etc. – The Agency is more prudent in financial management and some of these tools are gradually being procured
• Some companies do not maintain standards after product registration
• Populace not giving required information to the Agency
• Porous borders through which regulated products are smuggled into the country
• Illegal importation of regulated products
New innovations:
• The NAFDAC Act Cap N1 LFN and other Laws are being amended to amongst others, to be more explicit in some of her activities, to increase penalties for offenders
• NAFDAC is currently working on becoming a WHO Listed Authority. The WHO uses Global Benchmarking Tools to assess the Agency and there are 4 Maturity Levels. Currently, we are aspiring to get to Level 3 which will permit our country to manufacture vaccines because as an Agency we have to do Lot release which is a requirement for vaccine production. This will also improve trade because our products can compete favourably with products from the advanced countries with stringent Regulatory Authorities.
• ISO Certification. NAFDAC was ISO certified in 2019 and this has been renewed. By this, all our processes in the Agency are Standard Operating Procedures (SOP)-Driven which means all our formations carry out all our activities uniformly. This is a continuous improvement process and paradigm.
• Our ICT has been strengthened and is continuously being strengthened
• Pharmacovigilance which is the science of detecting, assessing and documenting adverse events has been strengthened. The Agency recently launched the MEDSAFETY App for reporting adverse drug reactions e.g. as the Covid vaccine is being administered to people and if there are reactions, no matter how little, they report it through the App which comes to the database and eventually to the Upsalla monitoring Centre in Geneva where Adverse reactions are domiciled internationally. Reactions to other drugs are also reported through the App.
• In conjunction with other stakeholders, the National Traceability Strategy has been launched for tracking and tracing medicines e.g. the Covid Vaccines to ensure fake products don’t get into the supply chain and also to monitor distribution of the products to avoid diversion.NAFDAC is leading the Traceability initiative as one of the two countries in Africa and will be working with other African regulatory agencies to establish the technology driven track and trace.
• Post Marketing Surveillance is being strengthened by using risk-based sampling and evaluation of regulated products to ensure fake, substandard, counterfeit and unwholesome regulated products are not in circulation. Any of such products seen are mopped up and destroyed.
• Our Investigation and Enforcement Activities are being improved
• Our activities at the Ports have also been strengthened using an internally developed software to monitor regulated products being shipped into the country. The Ports Inspection directorate has also being digitized to carry out its regulatory activities through the Single Trade Portal window.
• Staff training and stakeholder engagements are continuously being done to develop their skills and enlighten them more on our processes.
• Our services generally have improved but we have not yet arrived where we are going.
How can members of the public access you to start the process of being certified by NAFDAC? Any portal, contact information, websites, emails, social media handles, phone numbers etc.?
Any final word for our listeners or to Nigerians?
Members of the public can reach us through our website www.nafdac.gov.ng;
Email: [email protected]
And through the following toll- free numbers: 0700 NAFDAC (0700-1-623322) for enquiries.
For complaints: 0800-1-623322; through email: [email protected]
Social media handles:
Facebook: https://www.facebook.com/NafdacNigeria
Twitter: https://twitter.com/NafdacAgency
YouTube: https://www.youtube.com/nafdacnigeria
NAFDAC and Your Health: TVC (Mondays at 6:30 pm), NTA (Tuesdays at 8 pm)
NAFDAC and Your Health: FRCN (Mondays at 4:30 pm)
News Agency of Nigeria (NAN): www.nannews.ng Or www.nanprwire.com
My final words to the good people of Nigeria is that NAFDAC is here to serve you by safeguarding the health of the populace.
• Please buy medicines at duly registered pharmacy outlets. Check for NAFDAC number on and food or drug product). Do not add any chemical to your food except table salt or sugar in very moderate amounts
• Only take Covid-19 vaccine in government registered vaccination centre. Covid-19 vaccine is free. Take the vaccine to avoid the risk of getting Covid-19 disease
• We encourage individuals and companies to come forward and register their products which is the only way we can guarantee quality, safety, efficacy or wholesomeness of products.
• Again, we cannot work alone. We need your cooperation by ensuring that you comply with our Laws by dealing in only registered food, drugs, cosmetics, medical devices, packaged water, chemicals and detergents (all referred to as regulated products).
• Please kindly give us information on any company or individual violating our laws by manufacturing, importing, distributing, advertising, selling or using unregistered regulated products. We promise to keep your identity confidential.
• For those involved in drug or substance abuse, please seek help to stop the use of such substances. They are only destroying your life.
• As said earlier, we have offices in the 36 states of the Federation and FCT. We also have 8 zonal offices. If you check our website www.nafdac.gov.ng, the numbers to reach the state and zonal offices are written there.
