By Bennie Mundando
THE Zambia Medicines Regulatory Authority (ZAMRA) has demanded that those intending to put conventional medicine and herbal medicine in the fight against the COVID pandemic must be registered.
ZAMRA Senior Public Relations Officer Christabel Mutale Iliamupu today told The Scoop in a statement that this must be done with clear evidence to support the efficacy and safety of the said medicine.
“The Authority wishes to advise persons who intend to place on the market conventional, herbal and traditional medicines for purposes of treatment or management of COVID-19 to apply for authorisation from the Authority. The application shall include clinical trials data as evidence to support the safety and efficacy of the product.
“In a case of new chemical entities, herbal or traditional medicines, the applicant shall be required to apply for a clinical trial certificate; authorising them to generate the required clinical evidence to support the use of such a product. In addition, the Authority grants approval of advertising or promotion of registered medicines and allied substances,” Ms. Iliamupu said.
She said the Authority had not received any application for conduct of clinical trials or grant of marketing authorisation for conventional, herbal or traditional medicines for use in treatment or management of COVID-19.
“Furthermore, ZAMRA has adopted the African Vaccine Regulatory Forum (AVAREF) Strategy and Guidance for Emergency Preparedness which provides for expedited time-frame for processing applications for conduct of clinical trials.
“The Authority has intensified its post-marketing surveillance activities and any would be-offenders shall be prosecuted by law,” she said.