marketing authorisation
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…
Unlocking Opportunities for Rare Diseases and Cancer Treatments: Leveraging Joint EMA and MHRA HTA/SA Advice
At Pharma Design Limited, we empower developers of therapies for rare diseases and cancer to navigate the evolving European regulatory landscape. Recent EU and UK reforms offer significant advantages through joint advice mechanisms, enabling sponsors…
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…
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…
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…