News Medicine / Pharmaceutical


Selected News

TGA Proposes Publishing Therapeutic Goods GMP Inspection Outcomes
TGA Proposes Publishing Therapeutic Goods GMP Inspection Outcomes
The Therapeutic Goods Administration (TGA) has opened a consultation on plans to publish Good Manufacturing Practice (GMP) inspection outcomes and GMP certificates for therapeutic goods manufacturers, seeking feedback on how the information should be published and accessed.
Norway Reestablishes Medical Device Standards Committee, Invites New Members
Norway Reestablishes Medical Device Standards Committee, Invites New Members
Standard Norway (SN) has reestablished its national committee for medical device management systems and is now inviting more professional communities to participate in work on international and European standards for quality and risk management in medical devices.
Joint Commission Launches Healthcare Cyber Resilience Program With Future Certification Pathway
Joint Commission Launches Healthcare Cyber Resilience Program With Future Certification Pathway
The Joint Commission, a U.S. healthcare accreditation body, and the American Hospital Association (AHA) have launched a new Cyber Resilience Readiness (CRR) program for healthcare organizations.
PCA Opens Consultation on Revised Biobank Accreditation Program
PCA Opens Consultation on Revised Biobank Accreditation Program
Polish Centre for Accreditation (PCA) has opened a public consultation on a revised version of its DABB-01 accreditation program for biobanks, introducing clearer rules for accreditation scope descriptions and updates aligned with PN-EN ISO 20387:2021-01.
Vietnam Food Safety Institute Achieves GLP-OECD Status
Vietnam Food Safety Institute Achieves GLP-OECD Status
The National Accreditation Office for Quality (BOA) awarded OECD Good Laboratory Practice (GLP) recognition to the National Institute for Food Control (NIFC),
Italy Adopts ISO 22367:2026 for Medical Laboratory Risk Management
Italy Adopts ISO 22367:2026 for Medical Laboratory Risk Management
The Italian National Standardization Body (UNI) has published the Italian adoption of ISO 22367:2026, the revised international guidance standard for risk management in medical laboratories.
Dutch Initiative Prepares New Committee on Medical Device Environmental Impact
Dutch Initiative Prepares New Committee on Medical Device Environmental Impact
The Royal Netherlands Standardization Institute (NEN) is preparing a new committee focused on methods for assessing the environmental impact of medical devices, with the aim of helping shape Dutch input into future European and international standardization work.
Mexico Updates Medical Device Labeling Standard With New Safety and Digital Information Rules
Mexico Updates Medical Device Labeling Standard With New Safety and Digital Information Rules
Mexico’s Ministry of Health has published a revised version of NOM-137-SSA1-2024, the national standard that sets labeling requirements for medical devices sold in the country.
Sorsix Becomes First in Europe’s Public Health Sector to Earn ISO 42001 Certification
Sorsix Becomes First in Europe’s Public Health Sector to Earn ISO 42001 Certification
Sorsix has become the first organization in Europe to have governance for a live national healthcare system certified under ISO/IEC 42001, the international standard for AI management systems.
Indonesia Revises Good Cosmetic Manufacturing Practice Certification Rules
Indonesia Revises Good Cosmetic Manufacturing Practice Certification Rules
Indonesia’s National Agency of Drug and Food Control (BPOM) has issued new rules for Good Cosmetic Manufacturing Practice (CPKB) certification,
Inmetro Opens Pilot Accreditation Program for Brazilian Biobanks
Inmetro Opens Pilot Accreditation Program for Brazilian Biobanks
The National Institute of Metrology, Quality and Technology (Inmetro) has opened applications for a pilot accreditation program for biobanks in Brazil based on ISO 20387.
Accredia Passes EA Peer Evaluation for Biobanking Accreditation
Accredia Passes EA Peer Evaluation for Biobanking Accreditation
The Italian accreditation body Accredia has passed a peer evaluation by the European co-operation for Accreditation (EA), advancing the process for international recognition of Italian biobank accreditations under ISO 20387.

Global News

ISO 9001 Auditing Practices Group Releases First AI-Focused Guidance
ISO 9001 Auditing Practices Group Releases First AI-Focused Guidance
The ISO 9001 Auditing Practices Group (APG) has published new guidance on auditing  quality management systems that use artificial intelligence, marking the group's first publication dedicated specifically to AI. 
ISO 10993-6 Standard for Implantation Testing Updated
ISO 10993-6 Standard for Implantation Testing Updated
The International Organization for Standardization (ISO) has published a revised edition of ISO 10993-6, expanding guidance for implantation studies used in the biological evaluation of medical devices.
All 12 Recognized Food Safety Program Owners Apply for GFSI Version 2024 Recognition
All 12 Recognized Food Safety Program Owners Apply for GFSI Version 2024 Recognition
The Consumer Goods Forum's Global Food Safety Initiative (GFSI) has confirmed that all 12 previously recognized Certification Program Owners (CPOs) have applied for recognition against the GFSI Benchmarking Requirements Version 2024.
ISO 14002-3 Climate Guidance Advances to Final Draft Stage
ISO 14002-3 Climate Guidance Advances to Final Draft Stage
ISO 14002-3, a guidance standard for managing climate-related issues within ISO 14001 environmental management systems, has advanced to the Final Draft International Standard (FDIS) stage.
ISO/TS 23485 Nears Draft Technical Specification Stage Following Review of 300 Comments
ISO/TS 23485 Nears Draft Technical Specification Stage Following Review of 300 Comments
The International Organization for Standardization's (ISO) Technical Committee 210 (ISO/TC 210) is advancing work on ISO/TS 23485,
Global ACI Explains Which IAF and ILAC Documents Remain in Force During Transition
Global ACI Explains Which IAF and ILAC Documents Remain in Force During Transition
The Global Accreditation Cooperation Incorporated (Global ACI) has published a cross-reference tableshowing the status of former International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) publications.
Standards Behind the FIFA World Cup 2026
Standards Behind the FIFA World Cup 2026
As the FIFA World Cup 2026 gets underway across the United States, Canada and Mexico,
CEN and CENELEC Open Nominations for 2026 Standards+Innovation Awards
CEN and CENELEC Open Nominations for 2026 Standards+Innovation Awards
The 2026 Standards+Innovation Awards are now accepting nominations for individuals and projects that have contributed to standardization through research, innovation and education.
PEFC Launches Project Sourcing Certification for Construction Projects
PEFC Launches Project Sourcing Certification for Construction Projects
The Programme for the Endorsement of Forest Certification (PEFC) has launched a new Project Sourcing certification program for the construction sector.
Development Begins on ISO 59001 Circular Economy Management Standard
Development Begins on ISO 59001 Circular Economy Management Standard
The International Organization for Standardization (ISO) has begun development of ISO 59001, a future certifiable management system standard for the circular economy.
ISO 32212 Introduces Net Zero Transition Planning Framework for Finance
ISO 32212 Introduces Net Zero Transition Planning Framework for Finance
The International Organization for Standardization (ISO) has published ISO 32212:2026,
ISO 45010 Workplace Menstruation and Menopause Guidance Advances to Final Approval Stage
ISO 45010 Workplace Menstruation and Menopause Guidance Advances to Final Approval Stage
The International Organization for Standardization (ISO) has advanced ISO 45010, which provides guidance on menstruation and menopause in the workplace, has advanced to the Final Draft International Standard - FDIS stage.
We use Cookies