IFPMA and EFPIA back EMA’s initiative to increase transparency in the regulatory process

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) have released a joint statement backing the European Medicines Agency (EMA)’s initiative to implement extraordinary transparency measures in the context of COVID-19.
The transparency measures include:

  • speeding up the publication of key documents
  • accelerating the announcements of drugs included in the continuous revision and compassionate use programmes
  • implementing earlier deadlines for publishing public evaluation reports
  • publishing the complete version of the management plan as well as the clinical trials data used in support of the regulatory approval of the medicine or vaccine once marketing authorisation has been granted, while also protecting privacy rights.

Both bodies urge national regulatory authorities to integrate these measures into their evaluation and approval processes for medicines and vaccines.
Thomas Cueni, general director of the IFPMA said: “As an industry we recognise the important benefits to public health associated with making the results of clinical trials more widely available; we hope that these measures will help to increase trust in science and in the decisions that are guiding the development of medicines and vaccines for treating COVID-19.”
For further information read the elglobal article.

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Published 15. October 2020 in News, News EU, Press Release