Regulations and Guidance Q1 2021

Regulations & Guidance feature in our Q1 Industry Update from Christina Hägglund, QA Manager S-cubed Ltd.

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

COVID-19 Guidance & Information

Europe & World



MHRA Guidance Documents

Brexit Notice of Medicinal Products

Regulations & Guidance

Proposed Revision of ICH Q9(R1) Quality Risk Management

ICH Reflection Paper on Advancing Patient Focused Drug Development

EU Clinical Trial Regulation (CTR)

The EMA management board has confirmed that the first phase of the Clinical Trial Information System (CTIS) audit has been completed (the CTR becomes applicable 6 months after the EC confirms the full functionality of the CTIS). The focus is now on the quality and stability of the system and on improving usability, performance and reliability.

The go-live date for the CTIS is December 2021. There is an option to subscribe to the quarterly CTIS Highlights Newsletter (go to ‘Progress updates’ section)

Pharmacovigilance Guidance for Public Consultation

Post-Authorisation Procedural Advice for Users of the Centralised Procedure

Assent / Informed Consent Guidance for Paediatric Clinical Trials

Genetically Modified Cells

FDA Guidance

Data Protection

Access to Electronic Health Records (EHRs)

European Data Protection Board (EDPB)

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