Industry Insights for Q3 – 2019

Our Q3 Industry Insights from Christina Hägglund provides an overview of everything you need to know about the latest regulatory updates from around the globe. Need advice or support? Then get in touch.

Harmonising Global Regulatory Approaches to Innovation

Drug development, manufacture, marketing and distribution are global enterprises. Harmonising regulatory pathways across the globe has clear benefits, particularly for innovative products and technologies that may deliver therapeutic benefits to patients with life-threatening and serious diseases. Existing regulatory frameworks do not always meet the unique needs of innovative products however and new approaches may be needed.

The modernisation of ICH E8(R1) is the first step towards GCP renovation and harmonisation. The draft E8(R1) Guideline was released for public consultation in May. As part of the consultation process, ICH will hold a public meeting prior to finalising the revised E8 Guideline. This meeting will take place 31 October 2019 in Maryland, USA (a webcast option will be available).

In addition, during ICH’s biannual meeting in June 2019, the progress made by its Working Groups was reviewed and work on new topics for ICH harmonisation was discussed, including:

  • E6(R3) Guideline ‘Good Clinical Practice’ – revision of the existing ICH E6(R2) Guideline to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions, in line with the ICH Reflection Paper on GCP Renovation.
  • E2D(R1) Guideline ‘Post Approval Safety Data Management: Definition and Standards for Expedited Reporting’ – an update of the existing ICH E2D Guideline to incorporate pragmatic potentially risk-based approaches to the management of information from existing and new data sources, to enable a greater focus on the data sources that will optimise signal detection activities and public health.
  • a new guideline on non-clinical biodistribution studies for gene therapy products.

You can find the ICH Reflection Papers here.

Transparency of Trial Data & Access to New Medicines

EU and US Regulatory Agencies Act to Increase Public Access to Clinical Trial Data

The EU and US have delivered a significant element of the transatlantic Joint Statement agreed a year ago, which defines a commitment from both sides to reduce barriers and increase trade in several sectors, including pharmaceuticals. This could make it quicker and cheaper for both sides to bring medicines to market.

Press Release: EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers

EMA: Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 11 July 2019

Working with Patients, Patient Groups and GPs

The Association of the British Pharmaceutical Industry (ABPI) has published a new guide that explains how sponsors can work successfully with patients and patient groups. It addresses six key topics, providing practical guidance, tips and tools to support pharmaceutical company collaboration with patients and patient groups.

On 6 June 2019, the EMA and three key groups representing GPs and family physicians in Europe signed a joint statement committing to strengthening their interactions.

UK Speeds Access to Pioneering Treatment

New improvements to the UK’s Accelerated Access Collaborative (ACC) are intended to ensure that pioneering treatments are fast-tracked into the National Health Service (NHS) in order to reach patients quicker.

The ACC is designed to select the most promising new treatments, tests and medical devices at an early stage, and to steer them through the clinical development and regulatory approval process faster.

Clinical Trial Regulation (EU No. 536/2014)

UK Continues to Prepare for the EU Clinical Trial Regulation

Authorities in the UK are preparing for the new Regulation while the UK remains an EU Member State. This includes a ‘combined ways of working’ pilot, which is testing an integrated process for regulatory and research ethics submissions.

Q&As on EU Clinical Trials

The Eudralex volume 10 Q&A document has been updated to bring it in line with the changes required by the Clinical Trial Regulation. The updated sections are primarily Section 7 (safety reporting – Q&As 7.1–7.47) as well as Sections 1.15, 3.1, 5.2, 5.7 and 10.10.

Further updates will be published in the new future.


UK – Serious Breaches

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published data on serious breach reporting during 2018. Of the 100 referrals adjudicated, 76 were considered to be serious breaches by the agency. Most serious breaches were reported by sponsors (86%) and almost half (46%) affected patient safety.

The MHRA has also produced a guidance document for the Notification of Serious Breaches of GCP.

UK – Updated Blue Guide

In July 2019, the Blue Guide ‘Advertising and Promotion of Medicines in the UK’ was updated to the Third Edition, Second revision.

US – FDA Encourages Development of Biosimilars

Biological products are the fastest-growing class of therapeutic product in the US. The FDA has an abbreviated regulatory licensing pathway for biological products that are demonstrated to be biosimilar to, or interchangeable with, an FDA-approved biological product.

To further encourage the development of biosimilars, the FDA has issued several new guidance documents in recent months.

FDA Draft Guidance Documents

Clinical Trials during Pregnancy and/or Lactation

FDA Clarifies Statistical Issues in ICH E9

Tracking Real-World Data and Real-World Evidence

If you need to know more about how we can assist you with our services or products, feel free to get in touch. And we hope you find our updates useful and informative.