THE ESSENCE OF
REGULATION
Dr. Monica Hemben EimunjezeDirector, Registration and Regulatory Affairs, NAFDAC
at
The NAFDAC Product Registration Outreach (NaPRO)
Covenant Capital, Covenant Christian Centre
The Covenant Place (Beside National Theatre) Iganmu, Lagos
Thursday, 12th March, 2015
CONTENT• MANDATE
• ESSENCE OF REGULATION
• R&R
• STRUCTURE OF R&R
• SMALL BUSINESS SUPPORT DESK
• YOU WIN
• NAFDAC STRATEGIES
• CONCLUSION3/12/2015 6NAFDAC Product Registration Outreach
MANDATE
• NAFDAC was established by Decree 15 of 1993 asamended by Decree 19 of 1999 and now theNational Agency for Food and Drug Administrationand Control Act Cap N1 Laws of the Federation ofNigeria, 2004.
• This Act mandates NAFDAC to regulate and controlthe manufacture, importation, exportation,distribution, advertisement, sale and use of food,drugs, cosmetics, chemicals, detergents, medicaldevices and packaged water (known as NAFDACregulated products).
3/12/2015 7NAFDAC Product Registration Outreach
MANDATE…
Mission Statement:
• To safeguard public health by
ensuring that only safe, quality and
efficacious NAFDAC regulated
products are manufactured, imported,
exported, distributed, advertised, sold
and used.
3/12/2015 8NAFDAC Product Registration Outreach
To protect public health
By ensuring that only quality regulated productsthat are: safe
Efficacious
wholesome reach the market, and ultimately theconsuming public.
This is an immense task that requires undyingcommitment and comes with its own numerouschallenges.
Essence of Regulation
93/12/2015 NAFDAC Product Registration Outreach
NAFDAC Structure
3/12/2015 10
Drug Evaluation & Research
Chemical Evaluation & Research
Food Safety & Applied Nutrition
Pharmacovigilance and Post
Marketing Surveillance
Veterinary Medicine & Allied
Products
Presence in all 36 States and the Federal Capital Territory, Abuja)
Administration and Human Resource
Management
Finance & Accounts
Planning Research & Statistics
Registration & Regulatory Affairs
Ports Inspection
Laboratory Services
Investigation & Enforcement.
Narcotics & Controlled Substances
NAFDAC Product Registration Outreach
NAFDAC comprises of thirteen (13) Directorates:
Office of Special Duties in the Director General’s OfficePublic Relations & ProtocolAuditTechnical ServicesLegal
Life Cycle Approach
NAFDAC adopts a product life cycle approachto regulation and control of regulated products.
Product development – clinical trials
Inspections
Laboratory analysis
Licensing
Monitoring
Post Marketing Surveillance
Enforcement
Advert approvals
3/12/2015 NAFDAC Product Registration Outreach 11
R & R
• R & R Directorate is one of the thirteen (13)Directorates of the Agency, whose functionsare anchored on the provisions of the Drugsand Related Products (Registration, Etc)Decree No. 19 of 1993 as amended:
• ...No NAFDAC Regulated products shall bemanufactured, imported, exported,distributed, advertised, sold or used except itis registered in accordance with theprovisions of this decree.
3/12/2015 12NAFDAC Product Registration Outreach
Functions of R&R
Registration of foods, drugs, cosmetics, medical devices,chemicals, detergents and packaged water. Otherfunctions are as follows:
Formulating, Updating, Compiling and periodic reviewof standard specifications, regulations and guidelinesfor the production, importation, exportation,advertisement, sale and distribution of food, drugs,cosmetics, medical devices, bottled water andchemicals.
Approval and control of advertisement of food, drugs,cosmetics, medical devices, bottled water and chemicalsto ensure that advertisements are not exaggerated,deceptive or detrimental to the consumer.
• Monitoring of advertisement to ensure compliance andidentify illegal advertisements.
3/12/2015 13NAFDAC Product Registration Outreach
Structure of R&R: Divisions / Units
The Directorate is divided into the following Divisions :
Imported Food and Packaged Water (IFPW)
Food Products (Others) – (FPO)
Drugs, Herbals and Cosmetics (DHC)
Imported Drugs, Biologicals and Medical Devices (IDBM)
Animal Health Products and Finished Chemicals (AHC)
Regulatory Affairs Division (RA)
Adverts Control Division (AC)
3/12/2015 14NAFDAC Product Registration Outreach
Structure of R&R contd…
• Small Business Support Desk organizes and liaises with smallbusinesses to foster greater understanding of regulatory proceduresand also serve as enquiry point for clients on regulatory issues.
• Regulatory Intelligence Desk updates and keeps the Directorateinformed about regulatory decisions taken by other jurisdictions onissues that have the potential to impact on public health and to serveas a focal point with pharmacovigilance.
• Expedited Processing Desk co-ordinates all functions of theDirectorate that pertain to expedited processes such as AdministrativeApprovals and fast track approvals.
• In-house Capacity Building Desk organizes in-house trainings tobuild regulatory capacity of officers within the Directorate.
• International Desk was created January, 2013 to driveinternational collaboration and regional harmonization.
3/12/2015 15NAFDAC Product Registration Outreach
Small Business Support Desk (SBSD)
Small Business Support Desk (SBSD) organizes and liaises
with small business to foster greater understanding of
regulatory, registration procedures and also serve as enquiry
point for clients on regulatory issues.
Function
To improve access to information.
To promote productive interaction.
To provide timely feedback.
To clarify NAFDAC laws and regulations.
To foster greater collaboration and understanding.
To organize R&R Open days / Stakeholders fora.
3/12/2015 NAFDAC Product Registration Outreach 16
Activities of SBSD
Hosted several stakeholders’ fora.
R&R Zonal Stakeholders’ Forum for South-South.
Federal Institute of Industrial Research (FIIRO), Oshodi, Lagos.
Nigeria Chamber of Commerce Industry Mines and Agriculture – Women Group (NACCIMA-WG).
Pan West African Food and Beverages Exhibition Trade Fair (Food Bex)
The NECA’s Network of Entrepreneurial Women Workshop.
Small Medium Enterprise Development Agency of Nigeria (SMEDAN).
The Trade Mission of the Turkish Pharmaceutical & Medical Sector.
Nigeria-Pakistan Pharma Investment Forum
Participation at International Trade and Investment Fora Lisbon, Portugal
Bangkok, Thailand
Belgrade, Serbia
3/12/2015 17NAFDAC Product Registration Outreach
Youth Enterprise With Innovation in Nigeria
(YOU WIN)
There were four hundred and twenty eight (428) beneficiaries
with NAFDAC regulated products.
YOU WIN 1 – 166
YOU WIN 2 - 262
The 428 beneficiaries of the YOU WIN were all contacted.
Two hundred and seven (207) of them responded.
3/12/2015 NAFDAC Product Registration Outreach 18
Counterfeiting
• A major challenge faced by regulatory Agencies
around the world.
"А counterfeit medicine is one which is deliberately
and fraudulently mislabelled with respect to identity
and/or source.
Counterfeiting can apply to both branded and
generic products, and may include products with the
correct ingredients, with the wrong ingredients,
without active ingredients, with insufficient active
ingredients or with fake packaging.’’
193/12/2015 NAFDAC Product Registration Outreach
Counterfeiting: Global Picture
The WHO estimates
Wealthy economies - less than 1%
- 50% of internet sales.
In emerging economies - 10%
Developing world - 30%.
203/12/2015 NAFDAC Product Registration Outreach
Factors that Encourage Counterfeiting
• In Nigeria: A developing country.
Large population – 167 Million.
Good market size.
Low local production capacity.
Good buying power as oil producer.
Vast and porous borders - 924,000km2.
• Counterfeiters target
– Antimalarials, Antibiotics,
– Antihypertensives, Anti-diabetic agents,
– Life style drugs
213/12/2015 NAFDAC Product Registration Outreach
GENUINE FAKE
The advent of sophisticated printing technologies
makes visual detection with the naked eye almost
impossible.
223/12/2015 NAFDAC Product Registration Outreach
NAFDAC Strategies
Cutting Edge TechnologiesTruscan RFID Text Messaging Mini-labs
Review of NAFDAC Laws
Capacity Building
Improved CollaborationNational Regional International
Sustained Public Enlightenment Print/Electronic Media Grassroots Sensitization
3/12/2015 23NAFDAC Product Registration Outreach
International Collaboration
• ECOWAS member states
• WAHO
• INTERPOL
• MRAs of WHO member states
• WCO, WTO, OECD, WIPO, etc.
• WHO
• UNICEF
• DFID
• GAIN
• MI
• BMGF
• USP
• India
• China
• USA
• Argentina
• Canada
BILATERAL COLLABORATIO
NS
INTERNATIONAL ORGANIZATIONS
WADRANIMPACT
NAFDAC
243/12/2015 NAFDAC Product Registration Outreach
Capacity Building
This has been made a top priority through:
Human resource capacity development
Upgrade of our laboratories
Continuous training of officers to strengthen our
regulatory capacity.
253/12/2015 NAFDAC Product Registration Outreach
Upgrading of NAFDAC Laboratories
On 15th October 2010, His Excellency, the President and Commander in
Chief of the Federal Republic of Nigeria, Dr. Goodluck Ebele Jonathan,
GCFR commissioned the upgraded NAFDAC Ultra Modern Area
Laboratory in Agulu, Anambra State.
The laboratory was upgraded to international standards to further
facilitate international and WHO accreditation of NAFDAC laboratories.
263/12/2015 NAFDAC Product Registration Outreach
WHO Prequalification
We have actively encouraged the local pharmaceuticalindustry to work towards attaining WHO prequalification.
This will afford Nigerian pharmaceutical companies theopportunity to participate in international bidding of drugsand other pharmaceutical products.
First Medicals, manufacturers of auto disable syringes in Port Harcourt ,Rivers State, has obtained WHO prequalification for their products.
Four (4) Nigerian Pharmaceutical companies have been adjudged by theWorld Health Organization to have an acceptable level of compliancewith World Health organization’s Good Manufacturing Practice (GMP).
These are -
• Swiss Pharma Nigeria Limited
• Chi Pharmaceuticals Limited
• Evans Medical Plc
• May and Baker Nigeria Plc273/12/2015 NAFDAC Product Registration Outreach
Pharmaceutical Development Fund
• NAFDAC in collaboration with the Bank of Industry
(BOI) facilitated a Pharmaceutical Development
Fund in a bid to provide support to the
pharmaceutical sector and ensure an enabling
environment for the growth and development of the
local pharmaceutical industry.
283/12/2015 NAFDAC Product Registration Outreach
Reviewing NAFDAC laws to make more of adeterrent.
The current law stipulates a fine of N500, 000 or 15year jail term upon conviction.
The new law seeks life term jail and confiscation ofassets upon conviction, compensation for victimswhere the counterfeit product is found to be theproximate cause of severe bodily injury, as well asto make counterfeiting a non-bailable offence.
A whistle – blower clause is also proposed
Law Review
293/12/2015 NAFDAC Product Registration Outreach
Cutting-Edge Technologies
NAFDAC is spearheading global efforts in the use of Cutting-
Edge Technologies to fight counterfeiting.
TruScan (Raman Spectroscopy )
Minilab
Mobile Authentication Service (SMS TEXT Messaging)
We are the first Medicines Regulatory Authority to deploy and
use Truscan®, a hand held device, with resounding success at
borders and within the country to detect counterfeit
medicines on the spot.
303/12/2015 NAFDAC Product Registration Outreach
Truscan
• The Truscan is a hand-
held device used for on
-the -spot detection of
counterfeit medicines.
• Celebrated investigative
journalist, Dan Rather,
formerly of CBS, was in
Nigeria to see this
device in use first
hand.
313/12/2015 NAFDAC Product Registration Outreach
GPHF Minilab Test Kits:
We are utilizing the Global
Pharma Health Fund
Minilab Test Kits for speedy
evaluation of medicines.
It is a reliable, simple and
inexpensive method for
detecting counterfeit
medicines.
323/12/2015 NAFDAC Product Registration Outreach
Mobile Authentication Service (MAS)
NAFDAC has launched the
Mobile Authentication Service
(MAS) using Short Message
Service (SMS).
This technology has put the
power of detecting counterfeit
regulated products in the
hands of more than 80 million
Nigerian cell phone users.
333/12/2015 NAFDAC Product Registration Outreach
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 Labeling Other requirements to facilitate registration of
products.
Support Small Medium Enterprises (SMEs)3/12/2015 NAFDAC Product Registration Outreach 35
Conclusion
3/12/2015 NAFDAC Product Registration Outreach 36
•NAFDAC has adopted a holistic, multifaceted,
diverse and well coordinated anti-counterfeiting
strategy that trancends local, national and
international boundaries.
•Effective regulation is key to ensuring quality and
safety of regulated products.
•NAFDAC is relentlessly working with all relevant
stakeholders to ensure that all NAFDAC registered
products, irrespective of their origin are of good
quality, wholesome, safe and efficacious.