Latest Posts:
Search for:
Category

Pharmaceuticals & Biotech

Category
In EU Pharmaceutical Package

EU Pharma Package: How Significant are the Proposals for Orphan Medicines?

by , and 6 Mins Read

On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation.[1] We continue our analysis of the Proposals with this focus upon the changes concerning orphan medicines. 1.The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorisation and supervision of medicines. 2. The orphan designation criteria remain largely unchanged, meaning…

Read More
In EU Pharmaceutical Package

A New Dawn for the EU Pharma Regulatory Regime? The Commission’s Proposal to Revise the EU Pharmaceutical Legislation is Finally Published

by , and 5 Mins Read

Today the European Commission has finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical…

Read More
In Medical Devices

The EU Whistleblowing Directive and its Impact on Healthcare and Life Sciences Organisations

by and 2 Mins Read

The EU Whistleblowing Directive (the WBD) was due to be implemented across the 27 member states by 17th December 2021. There are a few major markets which have yet to implement (11 member states in total). But, with those that have implemented, we now have a good feel for the challenges the WBD poses for global employers. The WBD has an admirable underlying objective – to provide pan-EU protection against retaliation for whistleblowers.  But…

Read More
In Digital Health

Talking M&A Podcast: Trends in Healthtech and Biotech M&A

by 1 Min Read

Baker McKenzie partner Aarthi Belani, AbbVie head of immunology business development and acquisitions Rachel Strick, Flare Capital Partners co-founder Michael Greeley and Patient Square Capital founding partner Neel Varshney share their insights on M&A trends in the healthtech and biotech sectors for the third episode of the Talking M&A podcast. 🔊 Talking M&A Episode 3 – Spotlight on healthtech and biotech in partnership with #BakerMcKenzie, is available to listen to here: http://spr.ly/60473clHl 16 minute listen…

Read More
In Digital Health

EU Clinical Trial Information System (CTIS) Becomes Mandatory

by 3 Mins Read

In brief Starting from 31 January 2023, the Clinical Trial Information System (CTIS), provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area (EEA) countries. Key takeaways The single portal was launched on 31 January 2022, initiating the one-year transition period during which sponsors could choose whether to submit a clinical…

Read More
In Pharmaceuticals & Biotech

Upcoming EU Reforms in the Pharma Sector – a Pivotal Year of Change Ahead

by , and 4 Mins Read

In Brief 2023 is gearing up to be an interesting year for those in the life sciences sector, with upcoming reforms to the established regulatory and IP landscapes that will impact innovator strategies in R&D, commercialisation, and patent enforcement. While reforms are currently under draft by the European Commission, the key areas of anticipated change are highlighted in a newly published article in The Life Sciences Lawyer. “EU reforms in the pharmaceutical sector – a…

Read More
In Pharmaceuticals & Biotech

Long-Awaited New Social Media Guidance From UK’s PMCPA

by , and 2 Mins Read

In brief The first ever guidance on social media has been issued by the Prescription Medicines Code of Practice Authority (PMCPA) to help pharmaceutical companies apply the high standards demanded by the industry’s ABPI Code of Practice to all their online communications channels. The PMCPA Social Media Guidance 2023 has been produced in consultation with the Medicines and Healthcare Products Regulatory Agency (MHRA), the ABPI, and pharmaceutical companies. It includes advice for companies to help them use…

Read More
In Pharmaceuticals & Biotech

UKs MHRA announces extension of the European Commission Decision Reliance Procedure (ECDRP)

by , and 2 Mins Read

In brief The MHRA lifted some extra burden from the industry by extending the European Commission Decision Reliance Procedure (ECDRP) by 12 months until 31 December 2023. The ECDRP was introduced following Brexit and is available to medicines approved via the EU centralized procedure. Before 31 December 2023, in situations where a Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorisation Application (MAA) or…

Read More
In Digital Health

Decentralised Clinical Trials – 6 Takeaways from New EU Guidance

by and 7 Mins Read

In brief A new EU-level recommendation paper (“Paper”) sets out wide-ranging recommendations for sponsors of decentralized clinical trials (DCTs). The Paper is great news for sponsors facing an array of grey areas and gaps in regulatory guidance around DCTs. It provides guidance on common issues in designing and implementing DCTs: from documenting the delegation of tasks to digital service providers, to obtaining e-consents and how investigators should manage new streams of incoming data. The recommendations…

Read More
In Pharmaceuticals & Biotech

The UK’s Voluntary Scheme for Branded Medicines Pricing and Access rate set to rise (again), to 26.5% for 2023

by , and 3 Mins Read

The UK’s Department of Health and Social Care has announced that the voluntary scheme payment percentage (VPAS) for 2023 will be set at 26.5% of sales for 2023 (representing almost GBP 3.3 billion). This is a further major increase to last year’s VPAS significant rate rise to 15% (around GBP 1.8 billion, rising from GBP 0.6 billion in 2021). VPAS is an agreement between the Department of Health and Social Care (DHSC), NHS England and…

Read More