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European Commission › Pharmaceutical Industry › Regulatory Requirements

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Hogan Lovells

The European Commission tackles shortages of critical medicines through the Critical Medicines Act

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On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more

Hogan Lovells

Pharmaceutical and cosmetic companies targeted by revised urban wastewater treatment directive – A critical moment to assess legal...

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The European Commission has revised the Urban Wastewater Treatment Directive (“UWWTD”), which is instrumental in mitigating urban wastewater pollution across EU. This revision, prompted by emerging environmental challenges,...more

Goodwin

Regulatory Updates on Samsung’s Denosumab Biosimilars

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On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more

Hogan Lovells

Overview on the functioning of the trademark system in Europe - Pharma Marks Insights series: Part II

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As we have seen in the first article of our series, trademarks play an important role in the protection of your pharmaceutical and life science products and can add significant value. But to understand the benefits but also...more

K&L Gates LLP

Brussels Regulatory Brief: February 2021

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ANTITRUST AND COMPETITION - The European Commission Accepts Commitments from a Pharma Company to Stop Its Excessive Prices - On 15 May 2017, the European Commission (Commission) announced that it had opened formal proceedings...more

Hogan Lovells

The European Commission issues guidance concerning management of legacy devices in EUDAMED

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On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices in EUDAMED. Legacy devices are...more

Hogan Lovells

EU: New developments in the SPC manufacturing waiver legislative process

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Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more

Jones Day

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

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The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more

Hogan Lovells

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

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On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

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