The Zambia Medicines Regulatory Authority (ZAMRA) and the National Health Research Authority (NHRA) have signed a Memorandum of Understanding aimed at speeding up the approval and monitoring of clinical trials in the country. ZAMRA Director-General Makomani Siyanga said the agreement will reduce regulatory delays, harmonise requirements and strengthen the protection of participants involved in clinical […]
The Zambia Medicines Regulatory Authority (ZAMRA) and the National Health Research Authority (NHRA) have signed a Memorandum of Understanding aimed at speeding up the approval and monitoring of clinical trials in the country.
ZAMRA Director-General Makomani Siyanga said the agreement will reduce regulatory delays, harmonise requirements and strengthen the protection of participants involved in clinical research.
Speaking during the signing ceremony in Lusaka today, Mr Siyanga said the two institutions will work together in authorising and monitoring clinical trials, medicine safety monitoring, sharing regulatory information and building capacity.
He says the collaboration will also allow the two agencies to undertake joint inspections of clinical trial sites and rely on work conducted by each other, reducing the regulatory burden on researchers.
Mr Siyanga said the agreement is part of efforts to address gaps identified during a World Health Organisation-assisted global benchmarking assessment, particularly in the regulation of clinical trials.
He said the initiative is also critical to Zambia’s efforts to attain WHO Maturity Level Three, which would strengthen the country’s national regulatory system for medicines and vaccines.
Mr Siyanga said attaining the status would help open regional, continental and global markets for locally manufactured medicines, with potential socio-economic benefits for the country.
He described clinical research as the heartbeat of drug development, saying the partnership will help ensure that research is conducted efficiently while safeguarding the rights and safety of participants.
Mr Siyanga has further called on researchers, academic institutions and pharmaceutical innovators to take advantage of the improved regulatory cooperation.
He has also urged the media to widely disseminate information about the agreement to researchers, pharmaceutical manufacturers, ethics committees and the general public.
And NHRA Director and Chief Executive Officer, Professor Victor Chalwe assured researchers, sponsors, ethics committees and research institutions that the agreement is intended to make the regulatory process more predictable, transparent and efficient.
Professor Chalwe said NHRA is committed to ensuring that Zambia remains a competitive, credible and ethical destination for clinical research, while ensuring that the protection of research participants remains at the centre of regulatory activities
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