Rumbidzayi Zinyuke
Senior Health Reporter
ZIMBABWE is set to play a key role in strengthening pharmaceutical manufacturing standards across the region, with the Common Market for Eastern and Southern Africa (COMESA) seeking access to local manufacturing facilities to train regulatory and industry personnel from 15 Member States in Good Manufacturing Practices (GMP).
The four-day capacity-building programme, scheduled for Harare from November 24 to 27, will bring together 30 participants, with each participating country expected to send two delegates.
In a letter addressed to MCAZ Director-General Dr Richard Rukwata, COMESA Officer-in-Charge Dr Christopher Onyango requested assistance in securing access to three GMP-certified pharmaceutical manufacturing facilities to host the practical training sessions.
The programme is being implemented under the COMESA Support Towards Regional Pharmaceutical Sector Development (CSTRPSD), funded by the African Development Fund, which seeks to strengthen regulatory harmonisation, local pharmaceutical production and quality assurance across the bloc’s 21 Member States.
“Given Zimbabwe’s established local pharmaceutical manufacturing base and MCAZ’s recognised regulatory capacity, the Secretariat wishes to conduct the practical component of this training in Zimbabwe,” Dr Onyango said.
He said the training was designed to complement classroom instruction with direct exposure to manufacturing operations, allowing participants to gain practical knowledge of quality management systems and GMP requirements.
“The session is designed to give participants practical, facility-based exposure to GMP systems and quality management practices, complementing classroom instruction with direct observation of live manufacturing operations,” he added.
MCAZ has also been tasked with facilitating introductions and regulatory clearance for the visiting delegates, as well as advising on confidentiality undertakings and other site-specific requirements.
The training is expected to complement existing regional and continental initiatives aimed at strengthening medicines regulation, including the Southern African Development Community’s ZAZIBONA collaborative medicines registration procedure and the African Medicines Agency’s (AMA) work towards a harmonised continental regulatory framework for medicines and health products.
Dr Rukwata said the move was recognition of Zimbabwe’s progress in strengthening its pharmaceutical regulatory systems and local manufacturing sector.
“This is a welcome recognition of the regulatory capacity that Zimbabwe has developed and the progress made in strengthening its pharmaceutical manufacturing sector,” he said.
He said the World Health Organisation Global Benchmarking Tool (WHO GBT) assessment earlier this year had demonstrated the strength of the country’s regulatory systems and reinforced its responsibility to contribute to medicines regulation beyond its national borders.
“MCAZ remains committed to sharing its regulatory expertise and supporting regional initiatives that promote harmonisation, quality assurance and access to safe, effective and quality-assured medicines.”
As part of the practical component, the Medicines Control Authority of Zimbabwe (MCAZ) will take participants to three local pharmaceutical manufacturers – CAPS, COSPHARM and VARICHEM – where they will gain first-hand exposure to manufacturing operations and quality management systems.
Dr Rukwata added that stronger regulatory systems across the region would also create an enabling environment for pharmaceutical industrialisation and regional trade.
Through the CSTRPSD programme, COMESA is seeking to build stronger pharmaceutical regulatory systems and expand local manufacturing capacity across its 21 Member States, potentially contributing to improved access to quality-assured medicines and reduced dependence on imports.
