Article originally published in EURALex, issue 192, in March 2008

The European Commission has launched a consultation on proposed amendments to strengthen and rationalise the European Community (EC) pharmacovigilance rules and systems established by Directive 2001/83/EC and Regulation (EC) No 726/2004. Comments were sought from stakeholders by 1 February 2008. Grant Castle and Robin Blaney summarise the key proposals and discuss some of the issues that they raise.

Generally, the Commission’s proposals should be welcomed. They focus on improving patient safety and increasing the transparency of the pharmacovigilance system, while at the same time increasing efficiency and easing the administrative burden on marketing authorisation holders (MAHs). The proposals also give a legal basis to issues that to date have been dealt with only in guidance. This offers all concerned in the pharmacovigilance system greater legal certainty and should make it easier for the relevant authorities to enforce the provisions where necessary.

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Photo of Grant Castle Grant Castle

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management.

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management. He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products. He has developed considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, the former Soviet Union, Africa, the Near East, Japan, and Australia. His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.

Photo of Robin Blaney Robin Blaney

Robin Blaney has broad experience in the life sciences sector including involvement in corporate, commercial, litigation, data privacy, and regulatory matters. He has gained particular experience in licensing, collaborative, and commercial transactions for life sciences clients. His regulatory practice includes pharmaceutical, medical device…

Robin Blaney has broad experience in the life sciences sector including involvement in corporate, commercial, litigation, data privacy, and regulatory matters. He has gained particular experience in licensing, collaborative, and commercial transactions for life sciences clients. His regulatory practice includes pharmaceutical, medical device, food, and consumer product regulation.