MEDICINES REGISTRATION – SECTION PROFILE



Mr. Felchism Apolnar.

Acting Manager, Medicines Registration.

Introduction

Medicines Registration (MRE) is a section under the Directorate of Medicines and Medical Devices, 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.

Personnel

The Section is headed by a Manager who leads the team of Medicine Assessors (Drug Registration Officers). The section has different cadres of staff with various disciplines including pharmacy, human medicine, veterinary medicine and herbal medicines. Staff have adequate knowledge, expertise and experience for assessment of quality and clinical parts of the medicinal product application (product dossier).

Duties and Responsibilities of the Section

MRE Section performs the following functions in regulation of medicines in fulfillment of the Authority’s mission of protecting and promoting public health:-

  1. Review and evaluate documentation of products (human, veterinary medicines, antiseptics and disinfectants) applied for registration in Tanzania. The review involves the assessment of quality, safety and efficacy of the product applications;
  2. Review product labeling and information for all medicinal products applied for registration;
  3. Approve and register medicines which have been demonstrated to be of adequate quality, safety and efficacy;
  4. To update the relevant product registration database including the list of registered medicines, antiseptics and disinfectants for public use; Click here.
  5. Review of the applications for renewal of marketing authorization and variations;
  6. Evaluate promotional materials and advertisements applied for registered medicinal products;
  7. Approval of promotional materials and advertisements for registered medicinal products;
  8. Development and review of medicines regulations, various guidelines, standard operating procedures (SOPs) and manuals;.Click here.
  9. To attend and respond to customer enquiries related to product registration;

During discharge of the functions and implementation of the activities, the Section collaborates with the Medicines and Complementary Products Inspection and Enforcement Section, in matters related to compliance with Good Manufacturing Practice (GMP) for the facilities responsible for manufacturing, quality control and release of the finished pharmaceutical products. Compliance to GMP is one the major pre-requisite requirement for marketing authorization of the medicinal products.

Post marketing authorization

After the medical product is granted marketing authorization by the Authority, it remains the responsibility of the Marketing Authorization Holder (MAH) to ensure that the product continuously maintains its quality, safety and efficacy profile during its life time on the market. In addition, TMDA monitors these attributes through pharmacovigilance and post marketing surveillance activities. Marketing authorization for all medicinal products remains valid for a maximum period of five years, after its registration.