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
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
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
Guidance is available in the Internet.
On behalf of the European Compliance Academy (ECA)