Marta Miglietti

Marta Miglietti

Hogan Lovells

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EMA public consultation on revised policy on access to documents

The EMA has launched a public consultation on its draft new Policy/0043 on access to documents. The document describes the EMA’s approach in balancing public and private interests involved in requests for access to documents...more

3/20/2017 - Comment Period Documentation EU European Medicines Agency (EMA) Pharmaceutical Industry Regulatory Standards

EU - US mutual recognition of GMP inspections: agreement published

On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the Official Journal of the EU:...more

3/20/2017 - EU Manufacturers Mutual Recognition Agreement Pharmaceutical Industry Regulatory Standards

EMA pilot project on tailored scientific advice to support new biosimilars

In February 2017, the European Medicines Agency (“EMA”) will launch a pilot project to provide tailored scientific advice for the development of new biosimilars, i.e. biological medicinal products that are similar to a...more

2/3/2017 - Biosimilars Biotechnology EU European Medicines Agency (EMA) Pharmaceutical Industry Regulatory Standards

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