12 January 2021 – At lot happened in the second half of 2021 with respect to new real world research guidelines and regulations.

Most notably in the second half of 2021, we’ve seen guidance published by regulators (EMA, FDA and MHRA) on their expectations when applicants use real world data (RWD) and real world evidence (RWE) to support regulatory decisions, such as marketing authorisation applications (MAAs and NDAs) and label extensions.

The various guidelines (see below) include expectations with regards to the design, conduct and oversight of non-interventional studies and cover elements such as data access contracts, data standards, data integrity, audit trails, 21 CFR 11 compliance, risk-based quality management, monitoring, safety reporting and posting on clinicaltrials.gov.

• • EU – EMA Guideline on Registry-Based Studies
  • UK – MHRA Guidance on the Use of Real-World Data in Clinical Studies to Support Regulatory Decisions
  • USA – Draft FDA Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products 
  • USA – Draft FDA Guidance on Registries
  • USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data
  • USA – New FDA Draft Guidance for Industry: Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products

Significant updates in the second half of 2021, included:

• • New regulations and guidelines with direct applicability to real world research (Bulgaria, EU, Spain)
  • Changes to research ethics committee online application tools (France, New Zealand)
  • New research transparent requirements (UK)
  • National laws supplementing the EU Medical Devices Regulation (Denmark, Finland, Hungary)

Moderate updates in the second half of 2021, included:

• • New or revised national legislation or guidelines (Argentina, Canada, India, Norway, Poland, UK)
  • Updates to research Ethics committee/ institutional review board policies, procedures and guidelines (Bulgaria, Croatia, Latvia, UK)
  • Updated requirements for post-marketing surveillance studies (Australia)
  • New guidelines for registries and registry-based studies (EU, USA)
  • Guidance/draft guidance on the use of RWD and RWE to support regulatory decisions (UK, USA)
  • Informed consent (Latvia, Spain)
  • Revised NIS reporting requirements (UK)
  • Medical Devices (EU, Hungary, Lithuania, UK)
  • Digital Health Technology (USA)
  • Artificial Intelligence (USA)
  • Big Data (EU)

Minor updates in the second half of 2021, included:

• • New or revised legislation or guidelines (Brazil, Canada, EU, France, Norway, UK, USA)
  • General regulator updates (Australia, Finland, Germany, Hungary, USA)
  • Regulatory decisions based on RWE (USA)
  • Updates to research Ethics committee/ institutional review board policies, procedures and guidelines (Brazil, Bulgaria, Germany, Hong Kong, Hungary, Ireland, Lithuania, New Zealand, Norway)
  • Updates to pharmacoepidemiology guidelines (EU)
  • Data privacy and data access (Norway, UK)
  • Medical devices (EU, Switzerland, UK, USA)
  • ICMJE recommendations for publication of research results in journals (Global)
  • Revision 1 of ICH E8 (Global)

Full details of the real world research regulatory updates in the second half of 2021 can be found in our ‘H2 2021 Summary Report’.