Thread by @NafdacAgency

NAFDAC’s Position on Local Claims for #COVID19 Remedies
#NafdacRelease

Read more here ⬇️⬇️
nafdac.gov.ng/nafdacs-positi…

NAFDAC as at the time of this press release has only received application from one company for a product the company is presenting (for approval) for the treatment of the symptoms, and not for the cure of #COVID19 as a disease.

A claim of cure must be subjected to clinical evaluation through well controlled, randomized clinical trials following an approved clinical trial protocol.

As the Agency that has been saddled with the mandate of safeguarding the health of the citizenry, NAFDAC will continue to make sure that only medicinal product (including herbal remedies) that have proven safety data will be approved for use by the public.

Presently, NAFDAC lists herbal medicines based on historical perspective on the use of the products after carrying out toxicological & microbiological evaluations in the labs to ensure that they are, at the minimum, safe. The listing status is valid for two years and is renewable

It does not validate the efficacy claims being made for the products hence, the labels must bear a disclaimer informing the consumer "The claims have not been evaluated by NAFDAC". This minimum requirement of ‘proof of safety’ is the Agency’s way of encouraging production...

...of herbal remedies from the country's rich diversity of plants.

Part of the efforts to advance herbal products development informed the setting up of the Nigerian Herbal Medicine Product Committee (HMPC) by the @DGatNAFDAC.

The platform brings together Manufacturers, Academia, Researchers and relevant stakeholders by bridging the gap often created between traditional medicine practitioners (possible patent holders) and drug manufacturers, whose responsibility it would be to formulate the products.

This collaboration, brokered by the Agency, aims at translating research of herbs into products of commerce with proven safety & efficacy. The committee has met three times since inception, March 15, 2019, September 6, 2019 and a virtual meeting on Thursday May 8, 2020.

Call for expression of interest for the #COVID19 related medicines was made; several researchers and practitioners have responded and are being guided to submit such medicines to NAFDAC for expedited review.

The Agency continues to encourage all stakeholders to present the products of their research findings and allow these remedies go through internationally recognized process of approval through pre-clinical and where applicable, clinical trials.

Finally, as the body with the mandate to regulate the conduct of clinical trials in the country, NAFDAC is committed to encouraging and supporting sponsors with appropriate guidance to expedite the development of effective interventions to treat or prevent #COVID19.