Pharmaceutical News and Updates

EMA PIP Reference numbers

Historically (and still referenced in many older documents and systems like EudraCT), the final EMA decision on a Paediatric Investigation Plan (PIP) was commonly identified by a short “P reference number” in the format P/xxx/yyyy…
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Medicines for Human Use (Clinical Trials Amendment) Regulations 2025 coming into full effect on 28 April 2026

The UK’s clinical trials framework is set for a major update with the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 coming into full effect on 28 April 2026. This represents the most significant…
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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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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…
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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’s New Guidance on Non-Standard Trial Designs: Unlocking Flexibility for UK CTIMPs

On October 15, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) released draft guidance on non-standard Clinical Trials of Investigational Medicinal Products (CTIMPs), marking a pivotal step in modernizing the UK’s clinical research framework.…
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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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CTA Applications in Europe

What distinguishes Pharma Design from other service providers is that we offer cost-saving, targeted and dedicated support with a team of very specialised consultants. Our prices are competitive thanks to our lean and flexible business…
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