The European Commission’s proposal to amend the EU’s general pharmaceutical legislation includes a new draft directive replacing Directive 2001/83/EC (the draft Directive) and a new draft regulation replacing Regulation (EC) No 726/2004, which will also incorporate the EU’s amended paediatric and orphan medicine rules (the draft Regulation
Continue Reading EU Pharma Legislation Review Series: Marketing Authorisations
As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“the Proposal”), the European Commission (“Commission”) has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages. In particular, there are new obligations
Continue Reading EU Pharma Legislation Review Series: Supply Security and Shortages Control
The latest draft pharmaceutical legislation published by the European Commission (“Commission”) is set to shake up the regulatory exclusivity protections available to innovator pharmaceutical companies operating in the EU (as discussed in further in our previous blog). As part of these developments, the Commission has clarified the
Continue Reading EU Pharma Legislation Review Series: Bolar Exemption under Patent Rights
The EU’s latest draft pharmaceutical legislation contains some interesting developments on transparency matters, both in relation to access to documents and transparency around the funding of research and development of medicinal products.
Disclosure of documents in response to an
Continue Reading EU Pharma Legislation Review Series: Access to Documents and Transparency of R&D Funding
“Delays in clinical trials result in delays of potentially life-saving treatments”
The European Commission is streamlining the rules for clinical trials of medicines consisting of, or containing genetically modified organisms (“GMOs”). Under the current EU GMO framework, getting authorization for clinical trials of GMO medicines is a long and costly process. Industry groups have vocally criticized it; and the Commission itself has voiced the need for change.
The Commission proposes a single, centralized application for clinical trials of GMO medicines. The sponsor will include a detailed environmental risk assessment with the application. In turn, the Commission will exempt clinical trials from the scope of many GMO rules. The new system will be leaner, greener and will get potentially life-saving treatments to patients with less administrative delay.
The changes are part of the EU’s new package of revisions to the bloc’s common pharmaceutical regime, set out in a draft Regulation and a draft Directive, published by the Commission on 26 April 2023. The new GMO medicines rules are just one part of a range of environment‑focused reforms to EU pharmaceutical law set out in the proposals — for more information, see our post here.Continue Reading EU Pharma Legislation Review Series: GMO Medicines
Pharmaceutical companies take note: the EU plans to refuse marketing authorizations for environmentally-unfriendly medicines.
The EU has published a package of revisions to the bloc’s common pharmaceutical regime. Many revisions aim to reduce the environmental impact of human medicinal products. The key environmental measures include:
In this post, we lay out what pharmaceutical companies need to know about the key environmental measures.Continue Reading EU Pharma Legislation Review Series: Addressing Environmental Risks
The existing EU pharmaceutical legislation provides for a number of specific exemptions from the marketing authorisation requirement, including products supplied on a named patient or compassionate use bases; products compounded and dispensed in pharmacies (magistral and officinal formulations) and also for products necessary to respond to public health emergencies. Given
Continue Reading EU Pharma Legislation Review Series: Pharmacy and Hospital Exemptions
As part of its policy goal of promoting innovation, the Commission’s proposed Regulation creates the concept of a “regulatory sandbox.” If the concept survives the legislative process, the sandbox will be a structured, regulated and time-limited environment in which innovative technologies, products, services or approaches might be tested in a
Continue Reading EU Pharma Legislation Review Series: The Regulatory Sandbox – A Safe Space for Innovators to Grow
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU’s general pharmaceutical legislation. As expected, the Commission’s proposal represents a significant overhaul of the EU medicine rules. Not least the incorporation of the EU’s amended paediatric and orphan
Continue Reading EU Pharma Legislation Review Series: Paediatric Medicines
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU pharmaceutical legislation. The proposal includes a new draft Regulation, which will repeal Regulation (EC) No 726/2004, the Orphan Medicines Regulation 141/2000 and the Paediatric Regulation 1901/2006.
As expected, the draft Regulation significantly shakes
Continue Reading EU Pharma Legislation Review Series: Orphan Medicines