Regulatory & compliance

US FDA recognises GMP inspections from Belgian Federal Agency for Medicines and Health Products

Kaat Van Delm

In November 2018, the FDA recognised the Belgian FAMHP as being capable of carrying out good manufacturing practice (GMP) inspections at a level equivalent to those in the United States. On 1 March 2017, the European Union and the U.S. agreed to amend the Mutual Recognition Agreement from 1998, with regard to the “Sectoral Annex Read More

Has the Orphan Regulation met its aims? A critical review of the EU’s incentives regime for rare disease patients

Eveline Van Keymeulen

By the 1990’s the European Union had fallen behind other developed economies in the encouragement and support its pharmaceutical regulatory framework offered to the development of new treatments for rare diseases. The aim of the Orphan Regulation was to remedy this. In the article “Has the Orphan Regulation Met its Aims? A Critical Examination of the European Union’s Read More

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