Key Regulatory Challenge For The Pharmaceutical Sector

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1. What is a key regulatory challenge in your home country?

The key regulatory challenge for the Pharmaceutical sector (for Marketing Authorisation holders and Sponsors of clinical trials) in European Union is the new European Union Pharmacovigilance legislation to submit the information on Individual Case Safety Reports (ICSRs) related to medicinal products authorised in the European Union (EU) and investigational medicinal products (IMPs) studied in clinical trials authorised in the EU
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To ensure accurate updated information, EMA develop constantly new legislation.

In 2012, it became mandatory for Marketing Authorization Holders (MAHs) which maintain products in the European Union, whether centralized, decentralized, Mutual recognition or national to provide detailed structure data within 15 days for all human medicinal authorized products to Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).

The latest changes in the Pharmacovigilance regulation issued on January 31, 2014 with the legal notice on the implementation of article 57(2) of Regulation (EC) No. 726/2004. MAH’s should submit the updated information of Authorised product by 31st December, 2014.

MAHs shall electronically notify to the Agency information or any amendments to the terms of the marketing authorizations following variation, transfer, renewal, suspension, revocation or withdrawal no later than 30 calendar days from the date of which the amendments have been authorized. Moreover, more
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