Regulatory Updates

Regulations, Guidelines & Other Documents

A select list of recently released regulations, guidelines and other documents compiled by the ISPE Regulatory Quality Harmonization Committee (RQHC)’s Europe-Middle East-Africa Regional Focus Group

Feburary 2023

  • EC
    • EC delays deadline for MDR compliance​
      • The European Commission has approved a proposal to delay the deadline for companies to comply with the Medical Devices Regulation in order to prevent shortages of lifesaving equipment to end 2027/2028 depending on risk class). The proposal now needs to be adopted by the European Parliament and Council through an accelerated process.​
  • EMA
  • MHRA
    • Brexit update: UK maintains Acceptance of Batch Testing and EU Certification​
      • In a communication published at the end of last year, the UK Department of Health & Social Care clarifies that it remains committed to the acceptance of batch testing and certification by a Qualified Person (QP) carried out in the EU.
  • Who
    • The WHO has published its 56th Report of the Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP), on 22 December 2022, Technical Report Series (TRS) 1044.​
      • Several new guidance texts were adopted and recommended for use eg Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations; Points to consider when including Health Based Exposure Limits (HBELs) in cleaning validation; Good manufacturing practices: water for pharmaceutical use; Guideline on data integrity, etc​
  • Others
    • Brazil CP 1135/2022: specific criteria and procedures for the definition of Equivalent Foreign Regulatory Authorities for the GMP inspection process​
      • ANVISA published the public consultation (CP) #1135-22 (here in Portuguese). Open until 06-Mar-2023. It establishes the Regulatory Trust Building Program, which is a process applicable to Regulatory Authorities members of PIC/s or ICH only, aiming at mutual recognition of health inspection practices. This program will determine levels of regulatory trust for the EFRAs: partial, full, recognition.​
    • ​New Guidance Documents on Good Distribution Practice ​
      • PIC/S has adopted and published the following two guidance documents for GDP inspectors: an ‘Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain’ (PI044-1) and a ‘Questions & Answers (Q&A) document regarding the PIC/S GDP Guide’ (PS/INF 22/2017). ​
    • ECA QP Association issued VERSION 9.0 of the Code of Practice for QPs
      • The EU Directives and the EU Guide to GMP define some detailed requirements to be met by the Qualified Person (QP). The new version 9.0, launched in January 2023 now also comprises a new chapter "Ethics for the Qualified Person – A Professional Code of Conduct".​
  • FDA
    • MRA between the Swiss Confederation and the US Relating to Pharmaceutical GMP​
      • FDA and the Swiss Agency for Therapeutic Products (Swissmedic) will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections. Announcement​
    • FDA Recognizes First AI-Focused Document, AAMI CR34971:2022, in List of Consensus Standards​
  • ICH
    • ICH Q9 (R1) on Quality Risk Management has reached step 4 as of 18 January 2023 and is now proceeding to the implementation phase​.


A list of select Brexit updates compiled by the ISPE Regulatory Quality Harmonization Committee (RQHC)’s Europe-Middle East-Africa Regional Focus Group.