What’s new in clinical development practices & regulations.

Prepared by Christina Hägglund, Quality Assurance Manager

If you would like a pdf of this update you can download it here

BREXIT

UK Prime Minister Signals the Intent to Remain with European Medicines Agency (EMA)

Theresa May has unveiled the government’s desire for the UK to remain part of the EMA following its departure from the EU. Full details can be read in The Pharmatimes here.

EMA Relocation

At the EMA Management Board meeting in December 2017, the EMA shared details of preparations for its move to The Netherlands. The deadline for taking up residence is 30 March 2019.

The EMA reported that collaboration with The Netherlands commenced promptly and that agreement has been reached on the joint governance structure, with plans to progress activities within five work streams:

  • Temporary premises
  • Permanent premises
  • Staff relocation
  • Financial and legal aspects
  • External Communication

Read more about New tracking tool for EMA’s relocation to Amsterdam here.

Click to read the Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Medicines and Healthcare product Regulatory Agency (MHRA) Issues an Update on Preparations for Brexit 

On 15 December 2017, the European Council formally agreed that sufficient progress has been made to move on to the second stage of the negotiations. This followed the publication of a Joint Report on progress during the first phase by the Government and the European Commission.

The MHRA update can be read here.

International Conference for Harmonisation – ICH

ICH E8 ‘General Considerations for Clinical Trials’

ICH has proposed modernising of the E8 Guideline in order to incorporate the most current concepts, achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials.

Full details here: http://www.ich.org/products/gcp-renovation.html

ICH to Focus on Multiregional Trials and Paediatric Medicines

With the increasing globalisation of medicines development, ICH adopted a major guideline on the planning and design of Multi-Regional Clinical Trials (MRCTs). The E17 Guideline will facilitate the acceptability of MRCTs as part of global regulatory submissions in ICH and non-ICH regions, as well as making it easier to seek approval for global trials.

Following an agreement earlier in 2017 on the E11 Guideline on the clinical investigation of medicinal products in the paediatric population, ICH decided to establish a Paediatric Expert Working Group. The group will provide centralised and consistent cross-functional and multi-regional paediatric expertise to other ICH Expert Working Groups.

Full details here: http://www.ich.org/ichnews/press-releases/view/article/ich-assembly-geneva-switzerland-november-2017.html

Future Regulations & Expected FDA Guidance Documents

EU and UK General Data Protection Regulation (GDPR)

On 25 May 2018 the GDPR will come into force, representing the biggest change to Europe’s data protection rules in the past 20 years.

Data protection changes in 2018: what does that mean for research?

Full details of all regulations are on available via the ICO.

USA

On 19 January 2018, the Center for Drug Evaluation and Research (CDER) issued a list of the guidance documents it plans to publish in 2018.

Details can be viewed here.

USA

Food and Drug Administration (FDA)

DATA STANDARDS UPDATE:

The FDA published an FR notice at the end of January modifying the timings for new electronic data standards. When new standards are published, there won’t be separate IND and NDA requirement and sun setting dates.

Full details here: https://www.federalregister.gov/documents/2018/01/23/2018-01119/electronic-study-data-submission-data-standards-timetable-for-updates-to-the-food-and-drug

Other News Articles:

MISCELLANEOUS

Risk Adaptation in Clinical Trials

The level of risk to clinical trial subjects is dependent on the nature of the Investigational Medicinal Product (IMP) and the trial procedures. A risk proportionate approach to the design and conduct of clinical trials is supported by the current clinical trial regulations, but they do not explain how risk proportionate approaches, including risk-based monitoring, should be undertaken.

MHRA staff have shared their experiences of how risk proportionate approaches to clinical trial conduct – based on a proactive, well-documented and thorough risk assessment of the individual trial and IMP – can be successfully implemented.

Read the full report by clicking here.

EMA Issues New Advice on Regulatory Process for Advance Therapy Medicinal Products (ATMPs)

The update aims to streamline some procedural aspects, strengthen collaboration between the EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations. Read both documents below:

Pharmacovigilance Inspection Metrics Report

The UK’s MHRA Good Pharmacovigilance Practice (GPvP) Inspectorate completed 37 inspections during the 12 months to 31 March 2017.

Strike might affect Danish Medicines Agency from April

Danish Government in Search for New Notified Body