Regulatory & compliance

Belgian Royal Decree on clinical trials adopted

Eveline Van Keymeulen

Recently, the Belgian Government adopted a new Royal Decree regarding clinical trials (Royal Decree), which implements the law of 7 May 2017 on clinical trials with medicines for human use (Clinical Trial Law) (see our update, Belgium adopts law to prepare for Clinical Trial Regulation implementation). Both the Royal Decree and the Clinical Trial Law Read More

European Commission publishes roadmap for its joint evaluation of the Orphan and Paediatric Medicines Regulations

Eveline Van Keymeulen

Yesterday, the European Commission published an evaluation and fitness check roadmap for its joint evaluation of the legislation on medicines for children and rare diseases (medicines for special populations), i.e., the Orphan Medicines Regulation (EC) No 141/2000 and the Paediatric Medicines Regulation (EC) No 1901/2006. The evaluation will start in Q1 2018 – with a Read More

Brexit: EMA’s regulatory guidance on centrally approved medicinal products – the present state of play

Jacqueline Bore

The champagne bottles have been drained in Amsterdam and tears dried in Milan and Bratislava but the serious work of mapping out the practical implications of Brexit continues at the European Medicines Agency (EMA). The EMA and the European Commission issued a Notice in May 2017 confirming that “unless the withdrawal agreement establishes another date” Read More

European Commission clarifies framework applicable to food for special medical purposes

Patricia Carmona Botana

The European Commission recently published a Notice on the classification of Food for Special Medical Purposes (FSMP) that provides guidance to companies and national regulators on the legal framework applicable to FSMP and on the criteria that are required to classify a product as a FSMP (Notice). The Notice confirms that FSMP is in principle food Read More

Dutch Minister to explore possibility of compulsory licenses and pharmacy preparations

Anna-Maria Withagen

The Dutch Minister of Medical Care, Bruno Bruins, announced that he is going to explore the possibility of granting compulsory licenses in order to make pharmaceutical companies lower the prices of certain medicines they offer. During a debate, Bruins said that, although the instrument has not been used in the previous years, this does not Read More