The following information has been taken from the draft document:

“This paper addresses in general the strategy for the assessment of the quality of medicinal products containing known active substances. These include generic medicinal products but also those medicinal products which do not fall under the legal definition of generics. These active substances can be pharmacopoeial or non-pharmacopoeial substances.”

The paper also deals with general considerations:

“Article 10 of Directive 2001/83/EC, as amended by Directive 2004/27/EC, states that the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product.

From a quality risk management (QRM) point of view, each product should be considered on its own merit.

The manufacturer/applicant has to take full responsibility for his product, especially in those areas which are "site" specific i.e. those aspects where he can only rely on his own knowledge and competence (e.g. manufacturing, development, quality control). All the critical parameters of a generic product have to be addressed in the application file in the same way as for a new product. This does not mean that for some of these parameters the applicant cannot rely for instance on literature, if available, but he has to address them specifically for his product and his environment.”

The draft especially covers the topic “impurities”. It states:

“Under the development part of the application, it should be discussed whether the product is likely to have a different impurity profile as compared to the originator product.

Especially when this is the case, efforts should be made to keep the level of impurities as low as reasonably possible. Development work to keep the level of impurities low is performed for originator products, and this should not in principle be different for generic products. Where the level of impurities observed in generic products is higher than that in the originator, a discussion taking into account the active substance development and possible impurity sources (e.g. synthetic route, side reaction with excipients, production conditions during manufacture, etc.) should be provided by the applicant.”

The complete draft of the Draft Guidance is available in the Internet.

Prepared by:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)