Regulatory Updates

Aligning Regulatory Authorisation and Health Technology Assessment in Europe
US biotechnology companies developing innovative medicines increasingly target the European market for regulatory approval and subsequent patient access. In both the European Union (EU) and the United Kingdom (UK), recent procedural reforms have introduced requirements…
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EU Pharmaceutical Legislation reform
The EU Pharmaceutical Legislation reform (commonly called the Pharma Package) represents the most significant overhaul of EU medicines rules in over 20 years. It consists of a new Directive (replacing Directive 2001/83/EC) and a new…
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The MHRA-NICE Accelerated Aligned Pathway Pilot.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have launched the Accelerated Aligned Pathway pilot, a groundbreaking initiative designed to streamline the regulatory and health…
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The Cost-Effectiveness of Pharma Design Limited: A Practical Alternative to Traditional CROs for European Regulatory Support
In the competitive landscape of pharmaceutical development, regulatory affairs play a pivotal role in bringing innovative therapies to market. For developers, particularly those based outside Europe, navigating the complexities of EU and UK regulations can…
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MHRA and NICE Accelerated Aligned Pathway Pilot: Early Access for Faster Medicines Approvals
The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have launched a pilot for the Accelerated Aligned Pathway on October 10, 2025, six months ahead of…
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EMA’s new Variation Guideline: Three changes MA holders can’t ignore
Key summary: The recent revision of the EMA Variation Guideline (reference Regulation 1234/2008) overhauls post-authorisation change procedures (effective Jan 1, 2025). This amendment introduces faster processing for low-risk changes of Marketing Authorisations by introducing new…
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EMA meets industry stakeholders on scientific advice and clinical trial coordination
On 3rd July 2025 EMA conducted its annual meeting with representatives of industry stakeholders to address topics of evidence generation along the medicine’s life cycle and related product-development support activities, such as scientific advice…
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Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, so stop calling them so.
Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, therefore the very sexy terminology of ‘cancer vaccines’ is inappropriate. MHRA’s clarifies own definitions (https://assets.publishing.service.gov.uk/media/6799ef4d9a6dc0352ab34225/Individualised_mRNA_cancer_immunotherapies_0.6.5.pdf). More appropriately, MHRA states that such products are individualised…
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Paediatric Plans across Europe
A paediatric investigation plan or PIP is a requirement for any Marketing Authorisation Application in Europe (EU, Switzerland and UK). Even in cases where the medical condition targeted may benefit from a class waiver, any…
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EMA/HTA parallel consultation platform
On 30 June 2017 the EMA and EUnetHTA launched the new EMA/HTA parallel consultation platform. The new guidance replaces the former draft best practice guide as of publication date and has been developed from the experience gained with the SEED…
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