SECTION PICTURE

Mr. Felchism Apolnary Manager, Medicines Registration

Mr. Felchism Apolnary is a Senior Pharmacist, holding a Master’s degree in Science in Biotechnology Innovation and Regulatory Science from the University of Purdue, USA.

He joined TMDA in 2007, and before that, he worked in the pharmaceutical industry. Technically, he is an expert in medicine assessment, the quality part of the product dossier. He has adequate expertise in the review of scientific information/data related to the quality of active pharmaceutical ingredients and finished pharmaceutical products for human and veterinary medicines.

He has worked with regional blocs, EAC and SADC for the development of various harmonized guidelines and procedures for medicines regulation. He has also served as a facilitator in various regulatory trainings across SADC, EAC and IGAD regional blocs.

In addition, He has been actively involved in the development of various guidelines, guidance for the African Medicines Harmonization Program (AUDA-NEPAD-MRH), which, on moving forward, will be translated to the African Medicines Agency (AMA). Mr. Felchism is also a member of the Evaluation of Medicinal Products Technical Committee – AUDA-NEPAD/AMA.

Mr. Felchism is a consultant for the World Health Organization (WHO) as a technical advisor participating in the WHO Prequalification Team – Medicines, responsible for the assessment of medicinal products for prequalification. Also, he has adequate experience of the WHO Global Benchmarking Tool (GBT) Indicators - Registration and Marketing Authorization, Good Manufacturing Practices (GMP) Inspection of pharmaceutical manufacturing facilities, development and/or review of various policies, legislations/regulations, standard operating procedures (SOPs), process flow, forms, strategic and action plans related to medicines registration.

Introduction

Medicines Registration (MRE) is a section under the Directorate of Human and Veterinary Medicines, which deals with assessment of quality, safety and efficacy of human and veterinary medicines including vaccines, biotherapeutics/similar biotherapeutics, herbal medicines, antiseptics and disinfectants (biocidals). According to the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015; a medicinal product means any substance or mixture of substances manufactured, sold or presented for use in:-

1. The treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or the symptoms thereof, in man or animal;
2. Restoring, correcting or beneficial modification of organic or mental functions in man or animal; or
3. Articles intended for use as a component of any articles specified in clause (a) or (c); but does not include medical devices or their components, parts or accessories.

Scope of Products

The Section deals with registration of human medicinal products, veterinary medicinal products, herbal drugs and biocidals (antiseptics & disinfectant). The Section is also responsible for notification of tobacco products.

Personnel

The Section is headed by a Manager who leads a team of Medicine Assessors (Drug Registration Officers) of different cadres including pharmacists, veterinary surgeons, medical doctors and chemists. In addition to quality aspects of medicines, the staff have been trained in different specialty areas such as assessment of biotherapeutics, vaccines, promotional materials and clinical safety and efficacy data. Thus, the Section is well equipped with adequate knowledge, expertise and experience to ensure that the medicines registered in Tanzania Mainland meet the quality, safety and efficacy requirements.

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. Evaluate applications for registration of medicinal products;
2. Register medicines which have fulfilled the quality, safety and efficacy requirements;
3. Review and approved medicinal product labeling and information;
4. To update and publish information on registered medicines;
5. Evaluate and approve promotional materials and advertisements applied for registered medicinal products;
6. Development and review of medicines Regulations, guidelines, standard operating procedures (SOPs) and manuals;
7. To attend and respond to customer enquiries related to medicines registration;

During execution of the functions and implementation of the activities, the Section collaborates with the Medicines and Complementary products Inspection and Enforcement Section, in matters relating to Good Manufacturing Practice (GMP) compliance; and Clinical Trial and Pharmacovigilance Section on issues relating to the quality, safety and efficacy of registered products circulating on the market.