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Protocol
We welcome the various stakeholders – Pharmaceutical Manufacturers Group Manufacturers Association of Nigeria (PMG-MAN), Association of Pharmaceutical Importers in Nigeria (APIN), Association of Community Pharmacists of Nigeria (ACPN), Nigerian Representatives of Overseas Pharmaceutical Manufacturers (NIROPHARM), NAPPMED and Coordinated Whole Sale Centres (CWC), the Herbal Medicines and the Vaccines group, We welcome the press, other distinguished ladies and gentlemen.
NAFDAC has a statutory responsibility to safeguard public health through the execution of its mandate. We are charged with the responsibility to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, bottled and packaged water, chemicals – generally referred to as regulated products.
Upon assumption of office on November 30, 2017, I resolved to consolidate the gains of the past and take the Agency to greater heights. This requires that our approaches to regulation imbibe best international practices and are aligned with global regulatory standards as we strengthen our regulatory oversight. With a very wide mandate, I do appreciate and recognise the broad stakeholder base of the Agency.
“A Date with the DG” is expected to provide a platform for discourse and exchange of information, which relates to our expectations from the regulated sector and get feedback from you all, our stakeholders.
We are committed to strengthen our regulatory framework to enhance our efficiency and improve on our service delivery to you our stakeholders. Before the discourse, I will highlight some of the activities that we are undertaking in order to meet the goal.
ADMINISTRATIVE RESTRUCTURING: For effective administration, some directors were moved to strategic positions. In order to strengthen the zones and MSMEs six new directors were appointed through promotion. Considering the Lagos metropolis and the number of MSMEs, a new Lagos Area Office was created that will be led by a Director, similar to the FCT. In order to maximize the competencies of staff and overall output, some staff were transferred with input from the respective Directors. The outcomes have been very satisfying.
QUALITY MANAGEMENT SYSTEM: We are fully embracing institutional regulatory reforms for sustainability and are entrenching a Quality Management System (QMS) ISO 90001-2015 within the Agency. This is a strategic decision that is customer-focused, Agency-minded. The goal is to improve overall performance and provide a stable foundation for entrenching a quality culture within the scope of our activities.
INFORMATION COMMUNICATION TECHNOLOGY (ICT): To increase efficiency we have embraced fully the deployment and use of ICT in our operations. Our website has been revamped to increase transparency and we will continue to strive to build a more robust ICT platform.
We have enhanced our communication mode with the use of more secured emails, with all staff activating their official NAFDAC email to ease communication with you our esteemed stakeholders as well as fostering internal communication. Use of E-certificate for importation of registered products will be launched in two weeks. This will make easier to process Form-M on the Nigerian single window. Plans are underway for E-processing of application to approval to enhance ease of doing business especially for MSMEs.
In addition, to conserve resources otherwise spent excessively on travels, and to minimize risk associated with travel, a videoconference equipment was launched in March that has allowed staff to have meetings without traveling. This has cut down significantly traveling costs. The versatility of the technology was shown when I had to hold a 2-hour meeting with the staff in Lagos and Abuja while I was in Geneva.
LABORATORIES: We now procure needed supplies and standards directly from the manufacturers or USP directly. We are re-equipping and upgrading our laboratories by purchasing directly from the manufacturers. This is to cut cost and maintain the already attained ISO 17025 accreditations. We have continued to re-accredit our labs in order to keep the best practices and international standards platform. We are working toward getting a pre-qualification status for the Yaba Drug/Vaccines and Biological Labs. This will further enhance our regulatory activities as more manufacturing facilities obtain pre-qualification status in Nigeria
UPDATING REGULATIONS AND GUIDELINES: Regulation comes into play at various stages in the lifecycle of a product. This could be during product development, reformulation, manufacture, importation, and distribution or use to name a few. The various structures of the Agency are woven through the directorates that work cohesively with a view to ensuring that regulated products are of good quality, safe, efficacious and wholesome.
In order to ensure the effective discharge of our regulatory functions, the Agency has developed Regulations and Guidelines to aid compliance with regulatory provisions. We have recently revised 25 existing regulations and harmonised 65 guidelines. These have been posted and are available on our website.
CTD DEPLOYMENT: The agency has enforced the submission of applications for drug product approvals using the Common Technical Document (CTD) format for both new applications and renewal of old applications. This has raised the bar in the quality, safety and efficacy of medicines. The utilization of CTD encourages harmonisation, promotes good review practices and increased efficiencies, facilitates exchange of information and promotes compliance to international standards.
TRAINING OF STAFF: Many staff members (especially mid-level rank) are being trained on good manufacturing practices, dossier review, drug quality monitoring, regulations, blood-related products and Codex-focused emphases. The Zonal and State staffs are increasingly being trained in these areas. For any establishment, especially regulatory authorities, the QMS training is fundamental
REGIONAL MEDICINE REGULATORY HARMONIZATION (MRH) AND TRADE: NAFDAC continues to play significant role in the ECOWAS MRH in order to make it easier to trade with other countries in ECOWAS. This affords manufacturers to receive regional approval on already registered products by the respective National Regulatory Agency. Three products, registered by NAFDAC have been submitted for approval to the ECOWAS MRH body for approval. As Chair of the African MRH Steering Committee, we are working toward expanding opportunities for intra-continental trade along the same line.
SOURCE OF ACTIVE PHARMACEUTICAL INGREDIENTS (API): The quality of pharmaceutical product is dependent upon the quality of the active pharmaceutical ingredient used in its manufacture. To this end, we have developed draft guidelines for better quality standards of API’s used in drug manufacture locally. The Drug Master File that contains information on the quality of the API is a requirement for submission for desk review. The issuance of permit to import the API will be subject to result of the desk review. Also outcome of Desk review of API manufacturers could be shared to streamline submissions.
INSPECTIONS AND ENFORCEMENT: We have intensified our nationwide inspection of all facilities to ensure that current Good Manufacturing Practices (cGMP) are adhered to. We have also adopted a risk-based approach in the inspection of foreign facilities, which is aimed at making inspections more efficient and targeted at high-risk products and manufacturers. We have also adopted a style of sharing inspection reports with our stakeholders in line with global best practice. It will increase transparency and visibility to the inspections we carry out. Companies will receive the outcome of their inspections (satisfactory or unsatisfactory) in order to make informed decision on Corrective and Preventive Actions (CAPA) implementation, and improved understanding of relevant GMP concepts.
IMPORT PROHIBITION LIST/CEILING LIST: The policy thrust of government to drive national goals, and by extension, the Agency has a profound impact on the regulated sector. The Federal Government of Nigeria Import Prohibition list details products which cannot be imported into the country which include medicaments such as paracetamol, haematinics, co-trimoxazole, to mention but a few. The full list is available on the Nigerian Customs Service website. There is also the NAFDAC Ceiling that was put in place in 2004 for Pharmaceuticals. Many of the products that were initially on the NAFDAC ceiling were captured in the import prohibition list. In effect, there are 8 product categories on the NAFDAC Ceiling list and 14 pharmaceutical products on the import prohibition list. A total of 22 pharmaceutical products cannot be imported into the country.
The agency had a plan to limit the registration of imported pharmaceutical products to 10 years – that is one renewal only after an initial license of 5 years. Henceforth, this will be strictly enforced in order to encourage local manufacturing and to ensure access to essential medicines for our population.
SUPPORT FOR LOCAL PHARMA INDUSTRY: The Agency offers technical advice to manufacturers on matters such as factory location, grade of equipment materials, design / layout of factories and documentation requirements. We also conduct advisory inspections to guide our manufacturers on the right path towards achieving cGMP. Appropriate guidance and support are also given to establishments, depending on type and nature of products, intended for registration. We wish to state that we encourage the local manufacture of pharmaceutical products to meet medicine needs and ensure medicine security. We appreciate the commitment and investment of our pharmaceutical industries and look forward to expanding the range of locally produced drugs. We also encourage partnership with foreign companies and transfer of technology.
We are in relationship building with China and India toward partnership arrangement with local companies for local manufacturing of APIs and non-active ingredients. We are also including essential medicines and other therapeutics such as vaccines, blood products, antivirals, antimalarials, oncology, antidiabetics, parenteral antibiotics, and fixed dose combination products. It is worthy of mention that four pharmaceutical companies have their facilities certified by WHO-Pre-qualification (WHO-PreQ). The next push will be for the facilities to get their products approved through the WHO-PreQ mechanism. NAFDAC will ensure that this is realized through continued enablement of the manufacturers.
SERVICE DRUG SCHEME: It is critical that we ensure access to regulated products to meet certain needs and expectations – this is what informed the Service/Orphan Drug Scheme. The Service Drug Scheme is a special service provided to all pharmacies who intend to bring in products not currently registered to enable them meet the unmet medical needs of their patients/clients. The scheme is open to licensed pharmacists with valid premises license. Only limited quantity is allowed to be brought in and a tariff is charged per line item. It is worthy of note however that those items on the Federal Import Prohibition list and the NAFDAC Ceiling list are not allowed under the Service Drug Scheme.
ALERTS AND RECALLS: In an era of globalization, regulatory agencies the world over strives to strike a balance between quality and the safeguarding the health of the population. NAFDAC is remaining in sync with the global landscape and proactive as well as reactive as the case may be.
This has been evidenced by the series of alerts issued by the Agency in the face of threats as well as the recall of some products in the interest of public health. We thank you for your cooperation and responsiveness when we have had to handle such issues.
The Agency has remained undaunted in its efforts to reduce the incidence of substandard and falsified (SF) products as well as the smuggling and abuse of various products. The vulnerabilities of our population – fuelled by several social factors have been exploited and as an Agency, we remain focused in our effort to address these issues and have put in place better inspection plan with stricter regulatory measures.
RETURN OF NAFDAC TO THE PORTS: The return of NAFDAC to the Ports has restored the Agency’s key responsibility of regulating and control the import of regulated products. Our return to the Ports will address the issue of SFs, unprecedented assault on our nation by the smuggling of unregulated consignments of tramadol and the abuse of codeine containing cough syrups. We have restructured our formations at the various Ports within the country to improve our services. Measures are being put in place for electronic submissions and verification of documents to ease import clearance. Common violations observed by importers of regulated products are forgery and incomplete documentation, importation without authorisation, false declaration and concealment, evasion amongst others.
EASE OF DOING BUSINESS AND MSMEs: His Excellency, the Vice President Professor Yemi Osinbajo SAN, GCON on May 18, 2017 signed the Executive Order 001 (EO1) on Promotion of Transparency and Efficiency in the business environment. We have continued to work with the Presidential Enabling Business Environment Council (PEBEC) to deliver on this and improve service delivery of services to customer in a more transparent and efficient manner. With this in mind, we worked to clear a backlog of 6000 applications for registration nationwide.
The Decentralization of registration of certain regulated products commenced in April 2018. This was done to make approvals at the zonal levels more effective and the goals of MSMEs more realizable. This has been made possible after the creation of six zonal directorates and the FCT directorate.
PHARMACOVIGILANCE AND POSTMARKETING SURVEILLANCE (PV/PMS): The quality of product circulating within our jurisdiction is more of a focus and we are working focusing more on PV/PMS. We will be increasing our pharmacovigilance activities and spot checks to ensure consistent product quality. We have as a result developed relevant guidelines and documents to enhance pharmacovigilance and post marketing surveillance activities in the country.
RESEARCH: Within the regulated sector, the critical role of Research and Development (R&D) cannot be underestimated. As a researcher myself, I fully appreciate the role and potential of R&D. The potential cures of the future could be in our backyards and in our forests. The herbal remedies passed down by our forefathers have a role to play and we have a responsibility to encourage the research & development of such remedies.
The medicinal needs of our nation could be addressed by harnessing our local resource especially in herbal medicines. This will be fostered through synergy between academia and regulators.
CLINICAL TRIALS: The Agency regulates and controls the conduct clinical trials and reviews the clinical data from such trials. This is done to ensure the safety and efficacy of medicines. Clinical trial regulations and guidelines have been put in place to guide our stakeholders appropriately. The conduct of clinical trial is mandatory for the following category of products:
- New or relatively new molecule for which safety and efficacy has not been determined
- Drugs for new indication
- Drugs for new patient group (for example paediatric or geriatric)
- New combination of drug products
- New dosage schedule or regimen
- New drug delivery system
- Academic clinical trials
It is important to emphasize that no person should import, procure or manufacture any drug, medical device or cosmetic product for the purpose of clinical trial unless he or she is a holder of a valid Clinical Trial approval issued by NAFDAC. It is worthy of note that there are ongoing clinical trials in Nigeria at different sites. The Agency has built capacity and it expanding its capacity to cope with the continued scientific innovations in health research.
BASELINE STUDIES FOR VETERINARY MEDICINES: The Agency conducted a baseline study of veterinary drugs, and vaccines in two pilots states of Kano and Lagos. This is aimed at ascertaining the quality of veterinary drugs and vaccines in circulation.
BANNED VETERINARY DRUGS: It is important to inform you of some banned veterinary drugs. These are drugs that are not to be used in food producing animal either as therapeutic or prophylactic purposes because they have been found to cause cancer or maximum residue limit (MRL) have not been established by CODEX. The list of these drugs can be obtained from our desk outside.
COMPENDIUM: It is gratifying to mention that the Agency is in the process of publishing a Compendium of registered NAFDAC regulated products which has also been hosted on our website. The compendium is a veritable source of information and reference material for all stakeholders and consumers of NAFDAC regulated products.
In conclusion, the Agency continues the enabling of our manufacturing companies to ensure compliance, greater opportunities for local manufacturing of APIs and essential therapeutics. NAFDAC will encourage research that can drive our regulation of food, drug, herbal medicines and other regulated products. The Agency continues its regulatory controls in all sectors to safeguard the heath of the nation.
Thank you,
Prof Christianah Moji Adeyeye
Director General
