Regulatory Guidance COVID-19

Our Industry Update focuses on regulatory guidance and news on the impact of COVID-19 on clinical trials, the latest news about the EU Clinical Trial Regulation and much more.

As always, this quarter’s update has been expertly compiled by Christina Hägglund, QA Manager.

You can download a pdf of this update here and sign up to receive our updates via email here.

COVID-19 Guidance During the Pandemic




Regulations and Guidance

EU Clinical Trial Regulation (CTR)

On the 31 January 2022, the CTR 536/2014 will be implemented (the publication of the notice occurred on 31 July 2021): Clinical trials – Regulation EU No 536/2014 | Public Health (
The CTR has a 3-year transition period. Member States will use the Clinical Trial Information System (CTIS) immediately after the system goes live. Until 31 January 2023 (1 year after the go-live date), applicants can choose to submit their application to start a clinical trial under either the current system (the Clinical Trials Directive) or the CTR. From 31 January 2023, submission under the CTR becomes mandatory, and by 31 January 2025 all ongoing trials approved under the Clinical Trials Directive will need to transition to the CTR and the CTIS. Six-month countdown to go-live for the Clinical Trials Information System (CTIS) | European Medicines Agency (

The European Medicines Agency (EMA) has published a CTIS Sponsor Handbook

UK: Single Regulatory and Ethics Decision

In the UK, a combined review service will allow applicants to submit a single application that will undergo coordinated review from both the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Research Ethics Services. This change will happen on 31 January 2022, coinciding with the CTR go-live date. You can read more in the following links:

Voluntary Harmonisation Procedure (VHP)

The EU Clinical Trials Facilitation and Coordination Group (CTFG) has issued a deadline for VHP submissions. This includes any submission (initial, substantial amendment, second round) and there will be no exceptions. The deadline is midnight (CET) on 15 October 2021.

EMA and MHRA Guidance

FDA Guidance

  • Final Intended Use Regulation
    The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its medical product “intended use” regulations. This final rule amends FDA’s regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA’s implementing regulations, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use. This action also withdraws and replaces the portions of a final rule issued on January 9, 2017, that never became effective.
  • Sponsor’s Responsibility for Safety Reporting
    This guidance provides recommendations to help sponsors comply with the expedited safety reporting requirements for human drug and biological products that are being investigated (1) under an investigational new drug application (IND) (21 CFR 312.32) or (2) as part of a bioavailability (BA) or bioequivalence (BE) study that is exempt from the IND requirements (21 CFR 312.64(b) and 320.31(d)(3)).
  • Evaluating Cancer Drugs for Central Nervous System Metastases
    The purpose of this guidance is to describe FDA’s recommendations for clinical trial designs of cancer drugs or biological products regulated by CDER and CBER that are intended to support product labelling describing the antitumour activity in patients with central nervous system (CNS) metastases from solid tumours originating outside the CNS.
  • Patient Reported Outcomes (PROs) in Oncology Clinical Trials
    This guidance provides recommendations to sponsors for collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. Although this guidance focuses on patient-reported outcome (PRO) measures, some of these recommendations may be relevant to other clinical outcome assessments (i.e., clinician-reported outcome, observer-reported outcome, performance outcome) in cancer clinical trials.

Data Protection

The European Commission (EC) Adopts Adequacy Decision for the UK

On 29 June 2021 the EC announced the approval of adequacy decisions for the UK. This means that data can safely flow to the UK from the EU and the European Economic Area (EEA) without further safeguards – Data transfers to the UK will be treated as within-EU transfers.

UK Information Commissioner’s Office’s (ICO’s) has issued a guidance relating to anonymisation and pseudonymisation. Anonymisation is a privacy-friendly way to harness the potential of data, including when developing new and innovative products and services. Effective anonymisation of personal data is possible in many circumstances. It depends on the techniques you use. You need to reduce the risks of identifying individuals to a sufficiently remote level so that the information is effectively anonymised. This guidance will help all organisations that seek to anonymise personal data, for whatever purpose.

ICO’s draft international data transfer agreement (IDTA) and guidance – this will replace the Standard Contractual Clauses (SCCs). 

Regulatory Alignment & Patient Focused Drug Development

Regulatory Bodies’ Strategic Plans

Collaboration Between EMA and the European Network for Health Technology Assessment (EUnetHTA)

EMA and EUnetHTA have worked together since 2010. Together they have performed regulatory evaluations as well as Health Technology Assessments (HTAs) which have speeded up patients’ access to innovative medicines. Technical reporting – work plan 2017-2021, May 2021.

ICH Assembly Reflection Paper

The updated version of the Patient Focused Drug Development reflection paper includes modifications based on public stakeholders comments. The paper presents opportunities for the development of new ICH guidelines to provide a globally harmonised approach which incorporates the patient’s perspective.

 FDA Using Clinical Outcome Assessments (COAs)

COAs provide information on a patient’s health status (such as how a patient feels, functions or survives). The FDA uses COAs for regulatory decision making when evaluating medical devices. Clinical Outcome Assessments (COAs) in Medical Device Decision Making | FDA


MHRA GPvP Inspections Highlight need for Improved Risk Management

In order to ensure the safe use of medicines, Marketing Authorisation Holders (MAHs) need to adhere more effectively to risk management activities, including risk identification, risk assessment, and risk minimisation and prevention. MHRA GPvP Inspection metrics 2019-20 (

EC Consultations

Targeted stakeholder consultation on the amendments to (EU) 520/2012 on pharmacovigilance activities. 
As part of the Pharmaceutical Strategy for Europe, the Commission is not only committed to evaluate and review the general pharmaceutical legislation, but also to update and optimise existing implementing measures like the IR. The overall experience with the IR is good. However, following consultation with the EMA and the Pharmacovigilance Risk Assessment Committee, the need for some targeted amendments has been identified to take account of the experience gained and to update certain provisions in view of new technical standards being applied. The aim of this consultation is to inform and consult on those amendments.

If you require support or advice with any issues raised by this latest industry and Clinical Trials update, please contact us here.