From July the EC will require that gelatin used in parenteral drugs is sourced from countries in World Organisation for Animal Health's (OIE) lowest risk categories for bovine spongiform encephalopathy (BSE).
The new requirement states that: “Gelatin introduced in products for parenteral use should only be manufactured from bones sourced from OIE categories A or B countries.” In contrast, Gelatin used in oral drugs can come from any country.
The OIB categories replace those in previous versions of the guidance, the geographical BSE risk (GBR) critera, which were developed by a European Commission science committee as a temporary classification system.
At present European Directorate for the Quality of Medicines & Healthcare (EDQM) certificates of suitability (CEP) for gelatin do not take into account the final use of the product in which it is included.
This means, to be compliant with the new rules, pharmaceutical manufacturers whose filings include a gelatine CEP must prove the source of gelatin is suitable for the intended use according to the OIB critera.
European Medicines Agency (EMA) spokeswoman Vladimira Yalmanova told in-Pharmatechnologist.com that: “The guidance note establishes the criteria for the sourcing and processing of materials derived from 'TSE relevant animal species' in order to minimise the risk of transmitting animal spongiform encephalopathy.
“Compliance is ensured when the criteria stated in the guideline are met by the manufacturers,” she continued
Yalmanova also explained that the distinction between parenteral and oral drugs is based on animal experiments showing that the former pose the greatest transmission risk.
“With this respect, more stringent requirements are requested for this route of administration. These include sourcing from the lowest possible BSE risk countries or forum countries with controlled BSE risk.