THE IMPERATIVES OF REGULATORY PROCESSES PROCEDURES AND COMPLIANCE IN THE NIGERIAN BUSINESS SECTOR

1. THE IMPERATIVES OF REGULATORY PROCESSES PROCEDURES AND COMPLIANCE IN THE NIGERIAN BUSINESS SECTOR BY WILLIAM W. EFFIOK SPECIAL ASSISTANT TO DIRECTOR-GENERAL, NAFDAC @ MAY 21ST, 2019

2. CONTENT • Introduction • Structure of NAFDAC • How to we regulate • SBSD • Ease of doing Business • Regulatory Activities • Decentralization • Registration • Progress • Challenges • Pitfalls

3. Nigeria: Demographics Situated in West Africa Area: 923,768 km² Structure: 36 states Capital: Abuja Population: 167 million Adult literacy rate : 68% Below poverty line: 71.5% Development index: 156 GDP Per capita PPP USD: 2,600

5. MANDATE NAFDAC was established by Decree 15 of 1993 as amended by Decree 19 of 1999 and now the National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria, 2004. This Act mandates NAFDAC to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, chemicals, detergents, medical devices and packaged water (known as regulated products).

6. STRUCTURE OF NAFDAC • The Agency currently has 14 Directorates: • Registration and Regulatory Affairs (R&R) • Drug Evaluation and Research (DER) • Food Safety and Applied Nutrition (FSAN) • Pharmacovigilance and Post Marketing Surveillance (PVG/PMS) • Laboratory Services (LS) • Veterinary Medicines and Allied Products (VMAP) • Narcotics and Controlled Substances (NCS)

7. Admin & Human Resources (Admin & HR) • Planning Research and Statistics (PRS) • Investigation and Enforcement (I&E) • Finance & Account (F&A) • Port Inspection Directorate (PID) • Legal Services • Chemical Evaluation and Research (CER)

8. How do we Regulate? • Registration/licensing • Inspection • Post marketing surveillance • Laboratory testing • Advert control • Workshops • Creating awareness • Export control • Ports inspection • Enforcement and investigation • Narcotic control

9. Registration and Regulatory Affairs Directorate R&R is the Directorate of the Agency that is saddled with the following functions: Registration of:- • Foods • Drugs • Cosmetics • Medical Devices • Chemicals • Detergents and packaged water.

10. Other functions: • Updating and formulating standard specifications and guidelines for the production, importation, exportation, sale and distribution of food, drugs, cosmetics, medical devices, bottled water and chemicals. • Compilation of standard specifications and guidelines for the production, importation, exportation, sale and distribution of food, drugs, cosmetics, medical devices, bottled water and chemicals. • Approval, monitoring and control of advertisement of food, drugs, cosmetics, medical devices, bottled water and chemicals. • Formulation and periodic review of Regulations.

11. SMALL BUSINESS SUPPORT DESK To further improve and support the regulatory functions of the Directorate, the Small Business Support Desk (SBSD) was created in 2012. • SBSD was mandated to organize and liaise with small business to foster greater understanding of our procedures and also serve as enquiry point for clients on regulatory issues. • As the name of the Desk implies, it is dedicated to easing the registration process for small businesses • Improve access to information on NAFDAC regulated products

12. Functions of SBSD • Promote interaction between R&R and the Sectorial Groups • Provide timely feedback on enquiries relating to registration and regulations • Organizing open day and outreach programmes • To clarify NAFDAC laws and regulations to the regulated industry • To foster greater collaboration with the industry

13. SBSD Activities The NAFDAC Products Registration Outreach (NaPRO). • Further Strengthening engagement • Bring regulatory processes closer to the regulated sector • Seminar • Hands on interaction – Opportunity to have active engagement and advice on: • Documentation • Labelling • Other Requirements to facilitate registration of products

14. SBSD Activities Support Small Medium Enterprises (SMEs) • Standard Chartered Bank Manufacturer’s Business Forum Tagged “The Confluence” – May 17th, 2019 • Made in Nigeria Exhibition Abidjan Cote d’Ivoire 27th – 30th March, 2019 • Indian Pharma Expo 2019 , 12th – 14th March, 2019. • Nigerian Raw Materials Exposition (NIRAN) 2019, 12th -14th March • Nigeria Agro Foods Exhibition 26th – 28th March, 2019 • NaPRO 1st September, 2018, Covenant Christian Centre, Iganmu, Lagos – Annual tax & Business Compliance Seminar

15. EASE OF DOING BUSINESS • Office of the Head of Service issued a circular HCSF/2067/1/53 of June 19, 2017 to all MDAs to start implementing the Executive Orders with effect from 8 June, 2017. (Ranking of MDAs started on 8 June, 2017). • The Presidential Enabling Business Environment Council (PEBEC) through its Secretariat known as Enabling Business Environment Secretariat (EBES) are coordinating the implementation of the Orders.

16. EO1 The promotion of transparency and efficiency in the business environment designed to facilitate the ease of doing business in the country Support for local contents in public procurement by the Federal Government Timely submission of annual budgetary estimates by all statutory and non-statutory agencies, including companies owned by the Federal Government EO2 EO3

17. EASE OF DOING BUSINESS • Cleared backlogs • Decentralisation • ICT enabled • Regulatory reforms • Digitalization ongoing – single trade window www.trade.gov.ng • NAFDAC Automated Product Administration and Monitoring System (NAPAMS V2) www.napams.org

18. Reforms Achieved by NAFDAC on the EO1 Planks Transparency • Published reviewed Guidelines on the websites (on-going) • Published Risk Categorization for Foreign Facility Inspection • Developed Registration Timelines 90 Days • Service Level Agreements (SLAs). • Integration systems with Federal Inland Revenue Service, Nigeria Customs Service, Standards Organisation of Nigeria etc (e-certification) Transparency One Govt..

19. REGULATORY ACTIVITES • Pharmacovigilance / Post Marketing Surveillance • Streamlined Registration Process • Use of technology • Good Manufacturing Practice Inspections • Dossier Evaluation/Technical Review • Risk Categorization

20. DECENTRALIZATION • Bread and bread products • Packaged Water (bottle and sachet) renewal only • Dry finger foods – chin-chin, popcorn, plantain and potato chips. • Locally grown rice and other packaged farm produce. • Seasoning and spices • Palm oil • Honey • Hand wash, Liquid soaps, Hand wash, Car wash, Dish wash • Petroleum jelly • Fish and fish products (dried) • Meat and meat product (dried)

21. REGISTRATION One of the regulatory mechanisms for the control and regulation of the importation, manufacture and distribution of NAFDAC regulated products to ensure that they are safe, of good quality and efficacious is Registration/Licencing

22. The Registration Process Three thronged approach: • Documentation • Facility • Product

23. REGISTRATION STEPS

24. Documentation • Application • Application form • Artworks/labels • Trademark (if applicable)

25. Facility • Who owns the facility? • Contract? • Incubation Centre? • Inspection • Verification • Compliance with GMP/GHP

26. Product • Laboratory testing • Quality cannot be tested into a product

27. QUALITY • Inbibe a Quality culture • Quality Management System (QMS) • Organizational Structure • Defined roles and responsibility • Standard Operating Procedures (SOPs) • Personnel – training, knowledge? • Continual improvement • Customer Satisfaction

28. REGISTRATION 101 • Information is key • Educate yourself : www.nafdac.gov.ng • Regulations • Guidelines

29. REGISTRATION PITFALLS • Scam artists • Documentary deficiencies • Non-compliance to Compliance Directives (CD) • Labeling lapses • Unsubstantiated Claims • Facility status • Product failure • Formulation • Stability • Contamination

30. Progress Administrative reforms Entrenching QMS WHO Global Benchmarking Tool Laboratory upgrade Update of Regulations & Guidelines Inspection & Enforcement Alerts & Recalls Return to the Ports Post Marketing Surveillance Stakeholder engagement Ease of Doing Business (EoDB)

31. Engage NAFDAC Website: www.nafdac.gov.ng Emails: registration@nafdac.gov.ng, der.headquarters@nafdac.gov.ng, foodsafety.nutrition@nafdac.gov.ng, sbsdrr@nafdac.gov.ng

32. List of Technical Directors: Registration & Regulatory Affairs – eimunjeze.m@nafdac.gov.ng Ports Inspection – samson.adebayo@nafdac.gov.ng Narcotics and Controlled Substances – musa.umar@nafdac.gov.ng Investigation & Enforcement – kingsley.ejiofor@nafdac.gov.ng Pharmacovigilance/Post Marketing Surveillance – ali.i@nafdac.gov.ng Chemical Evaluation & Research – ngozi.onuorah@nafdac.gov.ng Drug Evaluation & Research – ijeoma.nwankwo@nafdac.gov.ng Food safety & Applied Nutrition – olagunju.s@nafdac.gov.ng Veterinary Medicines & Allied Products – edosaogbeide@nafdac.gov.ng Director Laboratory Services (Food) – nwachukwu.c@nafdac.gov.ng Director Laboratory Services (Drug) – abiola.v@nafdac.gov.ng

33. CONCLUSION We trust that this has provided some clarity on NAFDAC Regulatory/Registration processes and initiatives by the Government through Agencies to improve ease of doing business For more information on specific guidelines, please visit our website at www.nafdac.gov.ng