On 1 January 2021, EU pharmaceutical law ceased to be effective in Great Britain (GB), i.e., England, Wales and Scotland. Medicines and medical devices have since been regulated in GB under national law by the MHRA.

This July, the Scendea team made their way to Newmarket for an exciting day of horse racing, housed in the beautiful setting of the Champions Lawn.

From the 13th - 16th June, our Director Paul Cronin, Chief Financial Officer Charles Camp CGMA and Business Development Manager Stuart Hunter returned to Scendea’s largest event of the year, BIO 2022.

Getting a new drug to the patient involves numerous stakeholders that are part of a multi-faceted regulatory framework. This framework has evolved over time and proceeds from drug discovery to development to regulatory evaluation.

The 2022 Scendea Getaway was a fun-filled weekend spent enjoying time together as a team, learning about our new members and stepping out of our comfort zones.

Drug-device combinations (DDCs) are products that include both a medical device and medicinal product constituent part. There are two main types of combination products: Integral and Co-packaged.

From 31 January 2022 CTA submissions under the Regulation can start; at this point Sponsors have the option of filing under the new the Regulation or the existing Clinical Trial Directive (‘the Directive’).

In July 2021, MHRA published their two-year roadmap: ‘Medicines and Healthcare products Regulatory Agency Delivery Plan 2021-2023; Putting patients first: A new era for our agency’, within which scientific innovation, healthcare access and patient safety were called out as top priorities.

Paediatric drug development is a complex and challenging process, due to ethical, methodological, operational and financial limitations. Paediatrics are not a uniform sub-group and the medical needs, biological and physiological characteristics of neonates, for example, are very different to that of adolescents.

Successful approval of biological medicinal products in the EU and US require characterisation of biological products’ properties to enable the setting of specifications that control the molecule’s critical quality attributes (CQA) for release into the clinic and onto the market.

A biosimilar is a biological medicine that is highly similar to another biological medicine already approved. With a large number of blockbuster innovator products reaching their patent expiry dates in the next 10 years, biosimilar development continues to be a highly lucrative field.

A drug development tool (DDT) is a measurement or method (and associated materials) that aids drug development. DDTs can be used in a drug development program without it going through the qualification programs.

The role of regulators has expanded from not only safeguarding the quality and safety of products, but also to ensuring that guidelines evolve to consider the new generation of scientific technologies.

For a medicine to be approved, Sponsors need to demonstrate that it has a positive risk-benefit balance in the proposed target population, and is of satisfactory quality.

Click to read BDO’s latest published whitepaper in collaboration with the team here at Scendea.