Morocco is an emerging player in the global pharmaceutical market, thanks to its stable political framework and central localisation in the Mediterranean area. Both domestic and multinational pharmaceutical companies are present in the country. The local government is also supporting an ambitious health insurance program.
In March EIPG submitted its comments to EMA with reference to the targeted stakeholder consultation on Annex 1, responded to the questionnaire of the GMP/GDP IWG and QWP on the auditing of active pharmaceutical ingredients manufactures and attended the Industry stakeholder meeting on Brexit organised by EMA.
Topics of the new IMI Call 14 include control of immune-mediated diseases, non-invasive imaging, machine learning for drug discovery and decentralised clinical trials. The deadline to present applications is 14 June 2018.
China FDA proposed a collaborative project on the harmonisation of the clinical evaluation of medical devices at the international level during the 13th IMDRF meeting, that has been unanimously accepted. The new effort will aim to develop uniform standards and might result into the future amendment of the relevant European legislation on medical devices.
The European Commission has issued a new study on cross-border cooperation in healthcare, providing an highly fragmented insight across different regions, possible scenarios for the future, guidance to local and regional authorities and a toolkit to help implement the new initiatives.
The Spanish regulatory agency AEMPS has established an Office to support innovation and knowledge of medicinal products, to help independent researchers and small companies to develop their products
The two regulatory agencies EMA and FDA published their 2018 Work Plans: many new activities will modernise the approval reference framework on the two side of the Atlantic Ocean
China has become a true scientific leader in life sciences, with many clinical trials going on with innovative medicines. The Asiatic giant also overcame the US as per number of scientific articles published in 2016 and ranks at the second place for investments in R&D
Orphan medicines and rare diseases are an area of great investments by pharmaceutical companies, as they can benefit of a 10 years market exclusivity. Rules to obtain orphan designation and regulatory procedures differs between Europe and the US
During the last month EIPG's representatives participated to the General Assembly of VAPI UPIP and to the EPSA General Reception. A new joint statement on medicine shortages and more.