Regulatory Updates

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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Update to Orphan Product MAA variations

On November 18, 2016, EMA published an update to the post-authorisation guidance on MA extensions and type II variations to include further details on the information companies need to provide when submitting a Type II variation…
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The public consultation on Europe’s Paediatric Regulation

The Paediatric Regulation (Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products) was adopted in 2007 to address a serious gap in knowledge on…
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EMA publishes report on parallel Scientific Advice

EMA published a report on the pilot on its parallel regulatory-health technology assessment scientific advice with a Best Practice Guide. Background: Since 2010, the EMA has initiated a pilot project of parallel HTA-regulatory scientific advice,…
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