Thursday, 23 January 2020 14.00 - 15.30 h
Recently, with the inclusion of the Guideline ICH Q3D in the collection of "Scientific Guidelines", the EMA established the deadlines for its entry into force (see our news "The CHMP adopts the Guideline ICH Q3D as a 'Scientific Guideline'" of 21 January 2015). For drug producers, there is a relatively short transition period of 20 months to implement the requirements of the ICH Q3D; as of December 2017, the provisions for approved medicines will be mandatory.
On 27 March 2015, the EMA published a document entitled "Elemental impurities in marketed products. Recommendations for implementation". The targeted audience of these recommendations are pharmaceutical companies and the national regulatory authorities; the latter are to conform their activities to these recommendations in order to ensure a uniform approach. This should also reduce the workload in the processing of variations, which will then be evaluated according to the same criteria.
The main points of the "recommendations" are as follows:
It remains to be seen whether these recommendations will result in a standardised approach of the authorities of the EU Member States and how the pharmaceutical manufacturers will be supported in their efforts of a timely implementation of the requirements of the Guideline ICH Q3D. An article by the "Industry Coalition" in the March issue of the magazine "Pharmaceutical Technology Europe" which provides practical suggestions for conducting risk assessments is also very helpful in this context.