6/7 June 2023
The EMA Committee on Herbal Medicinal Products (HMPC) has prepared a new question and answer on herbal medicinal products, which has been included in the practical guidance for marketing authorization holders on the subject of contamination by nitrosamines. This now states that new marketing authorization / registration applications for herbal medicinal products (including traditional medicinal products) must include a risk assessment. Already authorized / registered (traditional) herbal medicinal products currently do not fall within the scope of the request for review, unless a marketing authorization holder suspects a risk of contamination.
Since very few data are available so far, there is no evidence that herbal medicinal products are contaminated with nitrosamine impurities. Nevertheless, for new approvals/registrations of (traditional) herbal medicinal products, a risk assessment is required to prevent and mitigate the presence of nitrosamines. Applicants should critically evaluate the possible reasons for the presence of nitrosamines in the herbal substance/preparation, taking into account the available evidence in the scientific literature. The risk assessment should also cover all other aspects, in particular all reagents, excipients and packaging materials used in the manufacture and storage of the starting materials and finished herbal medicinal products. Applicants should submit the conclusions of the risk assessment with the application dossier (e.g., under 3.2.P.5.5). If a risk is identified, testing is required to confirm or refute the presence of nitrosamines. If necessary, risk mitigation measures should be proposed.
Already authorized / registered (traditional) herbal medicinal products are for the time being not in the scope of the call for review; however, if a marketing authorization holder suspects a risk of contamination, this should be investigated and if nitrosamines are detected, this should be reported to the relevant competent authorities together with a proposal for risk mitigation measures.
The updated document "CMDh practical guidance for Marketing Authorization Holders" is available on the CMDh homepage.