EARAPA REGULATORY NEWSLETTER; Vol. 1 No. 4

Bilateral Mutual Recognition was signed between Rwanda and the United Republic of Tanzania NRAs; Rwanda FDA and TMDA

On 2nd August 2021, an Agreement/MoU was signed between Rwanda and the United Republic of Tanzania Governments for collaboration between the NRAs of the 2 countries; Rwanda FDA and TMDA.

The purpose of this MoU is to establish the cooperation for harmonization on regulatory requirements between Rwanda FDA and TMDA, in the following areas of; Product Registration, Good Manufacturing Practices ,Inspection, Quality audits, Good Clinical Practices Inspection ,Clinical Trials Control, Post-Marketing Surveillance, Quality Control Laboratory Testing, Research and Trainings Information sharing and other regulatory functions

Africa Pharmaceuticals Regulatory Affairs Summit 2023 was held from 8-11 Oct 2023 in Cairo , Egypt

East African regulatory affairs professionals association (EARAPA) , being association partner of the summit, feels proud to successfully complete the 3rd edition of PharmaRegAfriSummit 2023 from 8th-11th Oct 2023 in Egypt Cairo.EARAPA would like to thank organizers PRA Consultancy , Hubplus Events Madré Wilson and the team , Pioneer events , sponsors of the event, esteemed speakers and all the particiants to make this very well organized and memorable event come true.

Several regulatory experts from Africa NRAs and Industries from each corners of the continent presented thier insightful experiences and country specific regulatory updates in the field in both pharmaceuticals and medical device regulations. EARAPA, a part from being association partner of the event, had participated as a speaker and panelist for the session '' Regulatory updates in East Africa'' held on 9th October 2023 and Mr. Kassahun Abebe has given insightful remarks on Ethiopia pharmaceutical market, associated opportunities and recent regulatory updates in the country. On the other hand, Mr. Amos Atumanya from Uganda has presented on the Uganda's health system and regulatory updates. Mr. Christian Kapinga from Tanzania has given regulatory updates of medical devices and IVD regulation in Tanzania. Mr Christian emphasized that Tanzania has a plan to official WHO maturity level III audit for medical device regulation by WHO in early next year and aspires to be the first maturiry level 3 agency in the medical device regulation as happened in pharmaceuticals, 2018.

EARAPA also had fruitful discussions with Dr. Mona Al Moussli , founder and managing director of PRA consultancy , Dr. Winnie Ng'ang'a-Mwangi , chair person of Kenya Association of Pharmaceutical Industry (KAPI) and other regulatory agency delegates to foster our cooperation in the area soon.

AMRH calls for potential dossier assessors and GMP auditors to submit thier CVs and expression of interest to engage in respective RA functions, 13rd Oct 2023

AMRH Secretariat invites Expression of Interests from qualified dossier assessors and GMP inspectors to be engaged in evaluation of medicinal products applications and sites inspections respectively that will be submitted by applicants as part of the continental pilot project.

The scope of assignment for assessors shall be the evaluation of medicinal product dossiers (chemical and biological) in a Common Technical Document (CTD) format.

dministrative and Product Information including product labelling.Quality part (Active ingredients and Finished Products)Safety part (non-clinical data)Efficacy part (clinical studies or bio equivalence data)The inspectors will be responsible to assess the manufacturing sites/clinical sites compliance to GoodManufacturing Practices and/or Good Clinical Practices respectively based on the information received aspart of the CTD (Site Master File, GMP certificates, etc..). Inspectors are also expected to be involved inconducting on-site inspections as deemed appropriate by the GMP TC.

Assessors and inspectors selected through this process will work as independent experts. However, when selected, they will need to provide to the AMRH Secretariat a form signed by their head of NRAs endorsing their credentials and allowing them to contribute to this continental process before their candidature could be confirmed by the AMRH. The assessors and inspectors will receive an allowance or honoraria for the work performed for the AMRH Secretariat and will be expected to participate in assessments sessions convened by the AMRH from time to time as appropriate.

The desired qualification and experience for assessors are as follows:

Qualification:

Preferably pharmacists or any other related qualification on human medicines (with know-how of drug discovery and development, pre-clinical and clinical development of medicinal products, chemistry, pharmaceutical manufacturing, legal aspects, information technology, analytical approaches, pharmacology and toxicology, molecular biology, biotechnology, and chemistry)A higher academic qualification such as master’s degree in pharmaceutical sciences orbiological sciences, regulation and regulatory affairs or related fields would be an added advantage.

Experience:

A minimum of 5 years progressive experience as an assessor in a National RegulatoryAuthority in Africa (advanced level)With at least 3 years’ experience participating in joint assessments under RECs MRH projects. An experience as assessor for the WHO Prequalification program for medicines or vaccineswill be an added advantage.Assessors and inspectors selected will work under the confidentiality undertaking and conflict ofinterest policies from AUDA NEPAD.

Sudan Approves Egyptian Drug Authority (EDA) as a Reference for regulation of Pharmaceutical Products, Cairo announced on 17th September 2023

The National medicines and Poisons board of Sudan issues a decision to import Egyptian medicines that are not registered in Sudan within the list of unavailable medicines .The Egyptian Drug Authority announced that within the framework of bilateral cooperation relations between Egypt and Sudan in the pharmaceutical field, and in light of the keenness of Egypt and Sudan to complement them, the National Council for Drugs and Poisons has issued a decision to allow the import of Egyptian pharmaceutical products registered and approved by the Egyptian Drug Authority without requiring their registration in the State of Sudan, within the list of priority medicines for the needs of the State of Sudan.

The announcement was made in the press release by EDA after the ?meeting held between the two bodies and in the presence of industry partners in the two countries, which resulted in the opening of the Sudanese drug market to Egyptian medical products to ensure the rapid meeting of pharmaceutical needs in the State of Sudan.

The authority said, this is the result of the Egyptian Drug Authority's interest on continuous integration and cooperation with Arab and African countries, and to confirm the complementarity of Egyptian-Sudanese relations, and international and regional confidence in the supervisory role of the Egyptian Drug Authority and local pharmaceutical products.

Product recalled from Rwanda market

Rwanda Food And Drug Authority (RFDA) ordered statutory recall of three batches of AmoxiClav-Denk 1000/125mg Powder for oral suspension.The authority informed the general public of Rwanda about the recall of batches; B# 27296, 27297and 27298 of AmoxiClav-Denk 1000/125 mg powder for oral suspension manufactured by PenCef pharma GmBH/Berlin in its official letter dated on 18th September 2023.

According to the authority, the reason for the recall is the ‘ongoingongoing stability study and associated investigation indicated ‘’Change in appearance of individual sachets of AmoxiClav-Denk1000/125mg mg powder resulting in deviation in clavulanic acid content’

East Africa Regulatory Affairs Professionals Association (EARAPA) would like to remind other authorities of East Africa region to share the alert and make thorough respective market assessment for the similar batches sourced from the aforementioned Germany supplier.

Health professionals and/or users are also advised to immediately report to thier respective regulatory authorities for similar product defects before use.

EARAPA Regulatory cosultancy Division

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