SECTION PICTURE

Emmanuel Alphonce Nkiligi Manager, Medicines Control Inspection and Enforcement

Emmanuel Alphonce Nkiligi is a senior pharmacist working at TMDA. He holds a masters degree in Health Management, Planning and Policy from Leeds University UK and Post Graduate Diploma in Advanced GMP from Purdue /Howard Universities (USA) and SLF (Tanzania). Emmanuel has over two decades of experience in pharmaceutical products regulatory affairs and supply chain at the Tanzania Medicines and Medical Devices Authority (TMDA). He has participated and provided technical leadership and guidance on various national and international pharmaceutical regulatory functions including systems strengthening (SS), market surveillance and control (MSC), licensing of establishment (LI) and regulatory inspection (GMP, PMS and import and export control) targeting to protect and promote public by ensuring quality, safety and efficacious pharmaceutical products.

He currently also serves a TMDA focal person for WHO, SADC and EAC on substandard and falsified medical products (SFMPs), WHO Global Benchmarking Tool (WHO-GBT) assessor and AMRH / AMA -GMP Technical Committee member and Lead Inspector.

Introduction

Medicines Control Inspection and Enforcement (MCIE) is a section under the Directorate of Human and Veterinary Medicines which enforces the Tanzania Medicines and Medical Devices Act, Cap 219 by regulating the quality and safety of medicines and complementary products through import and export control, and inspection of the entire medicines and complementary products supply chain.

Section 106 of the Tanzania Medicines and Medical Devices Act, Cap 219 gives powers to TMDA inspectors to enter, at all reasonable time, any premises which are in the TMDA register and any other premises, stall, vehicle, vessel or conveyance for purpose of enforcing compliance with the Act.

Personnel

The section is headed by a Manager who currently leads a team of medicines and complementary products inspectors. The section is divided into sub-sections namely Import and Export Control, Good Manufacturing Practices (GMP) for Domestic and Overseas, and Coordination of Inspection activities especially special inspections, recalls and disposal off of unfit products including substandard and falsified (SF) medicines. Staff members have adequate knowledge, expertise and experience to perform effectively and efficiently their responsibilities.

Duties and Responsibilities of the Section

Some of the key functions performed by the section in the fulfillment of the Authority’s mission of protecting and promoting public health include the following:

1. Import and export control which involves processing and issuance of import and export permits for medicines and complementary products as per section 73 of the Act;
2. Registration and Licensing of premises dealing with importation of medicines and complementary products, and manufacturing facilities as required under section 21 of the Act; Click to view list of registered premises dealing with medicines and complementary products;
3. Inspection and Enforcement of medicines and complementary products as required under section 106 of the Act. Inspections conducted in the facilities could special or investigative, concise, routine, follow-up or re-inspection and audit inspection;
4. Good Manufacturing Practices (GMP) inspections of domestic and foreign pharmaceutical manufacturing facilities as required vide GMP Enforcement Regulations, 2018 (GN 295);
5. Good Storage and Distribution Practices (GSDP) inspection which ensures that medicines which reach the consumers maintain the quality, safety and efficacy specifications from release by the manufacturer;
6. Recall of unfit medicines including substandard and falsified (SF) from the market as required vide Regulations, 2015 (GN 313);
7. Disposal of unfit medicines and complementary products as provided for under sections 73 and 99 of the Act and its regulations (GN 313);
8. Promotion of domestic pharmaceutical manufacturers by dedicating an officer to deal with and facilitate all regulatory matters related to establishment of new pharmaceutical manufacturing facilities. Such matters include providing technical support through timely site visit and offering technical trainings to key personnel.

During discharge of its regulatory functions, the Section collaborates with the Medicines Evaluation and Registration Section, in matters related to registration of products from GMP inspected and complied facilities. Furthermore, the section work hand in hand with all TMDA Zone offices to perform regulatory inspection activities targeting to achieve the TMDA mission of protecting and promoting public health, which enforces the Tanzania Medicines and Medical Devices Act, Cap 219 by regulating the quality and safety of medicines and complementary products through import and export control, and inspection of the entire medicines and complementary products supply chain.

Section 106 of the Tanzania Medicines and Medical Devices Act, Cap 219 gives powers to TMDA inspectors to enter, at all reasonable time, any premises which are in the TMDA register and any other premises, stall, vehicle, vessel or conveyance for purpose of enforcing compliance with the Act.