EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
EMA Press release 12/07/2019
With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories.
EU Council adopts SPC waiver text voted in EP in April
The Council of the EU adopted on 14th May the SPC waiver text that was voted in the EU Parliament in April. The regulation, approved during the Agriculture and Fisheries Council meeting, still needs to be published in the Official Journal, and is expected to enter into force on July 1, 2019. The waiver affects all SPCs applied for after the regulation enters into force and the text adds that “…the exception should apply, therefore, from 1 July 2022 to a certificate that takes effect from the date of entry into force of this Regulation”.
The European Commission has adopted a Communication outlining a set of actions addressing the “Strategic Approach to Pharmaceuticals in the Environment”. The plan that the Commission presented on March 11th, identifies six action areas concerning all stages of the pharmaceutical life cycle, where improvements can be made.
EMA Booklet – From lab to patient
EMA has published a booklet describing the journey of a medicine for human use authorised through EMA, from initial research to discussions on patient access to medicines across the EU: From laboratory to patient: the journey of a centrally authorised medicine – Link.
SPC manufacturing waiver
On January 23rd, 2019, the European Parliament’s JURI Committee voted its amendments to the Commission’s proposal amending Regulation (EC 469/2009) concerning the supplementary protection certificate for medicinal products. For more information, download our briefing note. Download.