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).

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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.

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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

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NAFDAC Structure

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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

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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.

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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.

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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)

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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.

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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.

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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

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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.

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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.’’

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Counterfeiting: Global Picture

The WHO estimates

Wealthy economies - less than 1%

- 50% of internet sales.

In emerging economies - 10%

Developing world - 30%.

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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

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GENUINE FAKE

The advent of sophisticated printing technologies

makes visual detection with the naked eye almost

impossible.

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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

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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

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

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MAS Code Scheme

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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.

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Conclusion

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•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.

THANK YOU

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