MCAZ amends medicine registration requirements

THE Medicines Control Authority of Zimbabwe (MCAZ) recently reviewed the conditions of registration of medicines for better monitoring and analyzing the efficacy as well as the quality of imported and locally manufactured medicines.

By Kudakwashe Pembere

The Authority which effected this amendment since July 7, 2023, said they are there to ensure that safety, effectiveness and quality of a medicine is maintained throughout its life cycle.

This will see applicants having their medicines assessed after every five years in accordance with the current norms and standards.

Applicants are required to submit renewal applications for medicines every five years to assess the conformity of the medicine to current norms and standards, and consistency of the quality of the product,” said MCAZ.

“Risk management plans are also assessed where applicable to verify the safety and efficacy of the medicine.”

Added MCAZ, “Risk management plans are put in place for some medicines and describe the activities of the applicant to further characterise the safety profile during post-marketing and explains the measures that are taken in order to prevent or minimise the medicine’s risks in patients. Risk management plans are usually submitted for innovator products but are also required for some generic medicines when there is a concern about a risk affecting the benefit-risk balance.”

Under the new conditions, applicants should be prepared to do some post-registration studies for verification of the medicine’s quality and medicines.

“Active Pharmaceutical Ingredients (API) manufacturer(s), approved batch size(s) and approved label are now included in the annex of the registration  certificate as a ready reference for critical information regarding the registered product. Finished Pharmaceutical Products (FPP) manufacturers sometimes commit to perform certain studies post registration of the medicine to verify the quality and/or safety of the medicine. A list of these commitments is now also included in the annex to the medicine registration certificate,” said MCAZ.

This review, MCAZ said was necessitated by the need for further clarification of medicines registration conditions requirements in line with MASCA, including additional compliance with critical international good regulatory best practices to ensure that effective, quality and safe medicines are available to the public.

“The MCAZ registration conditions stated above are part of the legal provisions for existence of a national vigilance system based on requirements for sections 29(1)(b), 33(2)(iii), 33(3) and 34(1)(f) of the Medicines and Allied Substances Control Act (MASCA) [Chapter 15:03], MCAZ National Pharmacovigilance handbook 2016 Edition, MCAZ circular 1/2000 dated 21st March, 2000, MCAZ Pharmacovigilance Guideline for Pharmaceutical Industry MCAZ/PVCT/GL-02, Guideline for Pharmacovigilance of COVID-19 Vaccines MCAZ/PVCT/GL-03 and Zimbabwe National Adverse Events Following Immunisation (AEFIs) Guideline 2017.

“The use of the new format for the registration certificate will clarify all the registration conditions requirements plus product specific information to ensure compliance, and vigilance post-registration processes.

“The variation of the registration conditions and subsequent new registration certificate format, with the annexure, will be implemented with immediate effect from the date of publication of this notice,” said MCAZ.

 

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