EU: Agreement on the Pharmaceutical Package
On 11 December, the European Commission, the European Parliament, and the Council of the European Union reached a provisional agreement to update Europe's medicinal products regulatory framework (we reported).
Under the proposed regulatory changes, EMA would assess marketing authorisation applications within 180 days instead of 210, freeing up resources for increased pre-authorisation support. Marketing authorisations would also be granted for an unlimited duration, removing routine renewal requirements unless safety issues arise.
The proposal further provides eight years of regulatory data protection, plus one year of market protection, with the possibility of extending overall protection to up to 11 years if certain criteria are met, such as addressing unmet medical needs.
Next steps
The political agreement is still subject to formal adoption
by the European Parliament and the Council. Following its approval, EMA will,
over the coming months and years, work with the European Commission and EU
Member States to develop guidance to support applicants and marketing
authorisation holders in implementing the new legal framework.
Source:
EP: Deal on comprehensive reform of EU pharmaceutical legislation
EMA: News
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