Regulatory & compliance

General Court confirms strict significant benefit test on the grant of an orphan marketing authorisation

Jacqueline Bore

The General Court has confirmed in its judgment in Bristol-Myers Squibb Pharma EEIG v European Commission and European Medicines Agency (Case T-329/16) that the European Medicines Agency should take account of recently authorised medicinal products in determining whether a product under assessment should retain its orphan designation on the grant of a marketing authorisation. In the Read More

China announces pilot scheme for pharmaceutical tendering with minimum procurement quantities

David Shen

On 15 November 2018 the Joint Procurement Office (JPO) published its Paper on Centralized Drug Procurement in “4+7 Cities” (the Paper) which launched the national pilot scheme for tendering with minimum procurement quantities. The pilot scheme will be carried out in 11 cities: Beijing, Tianjin, Shanghai, Chongqing, Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu and Xian, Read More

New legislative proposals in Germany to encourage the use of biosimilars

Eda Zhuleku

The German Federal Ministry of Health recently released draft legislation on the safety of medicinal products – “Gesetz für mehr Sicherheit in der Arzneimittelversorgung” – GSAV In the wake of several recent safety issues, for example,  the release of contaminated pharmaceuticals with potentially carcinogenic substances in 2018, the government aims to improve the safety of medicines by stricter Read More

New measures on advertising and information of health products take effect in France

Eveline Van Keymeulen

In October 2018, Decree No. 2018-864 on the presentation, information and promotion of health products and related services entered into force, which was adopted pursuant to Article 58 of the Social Security Financing Bill. The decree introduces measures that aim to provide quality information to assist healthcare professionals in their therapeutic choices for health products, Read More

French Senate issues recommendations to tackle pharmaceutical supply disruptions

Eveline Van Keymeulen

In October 2018, the French Senate published a report on supply disruptions of medicinal products and vaccines. The report provides recommendations to combat the causes of such disruptions, which have increased by 30% since 2016, and to secure sufficient stock. In particular, the report proposes to: Set up tax exemptions for companies investing in French manufacturing Read More