Within the sphere of Good Practice (GxP) guidelines, a range of international agencies and their regulatory frameworks stand out for their global recognition, extending beyond the FDA's 21 CFR Part 11 in the United States. These frameworks aim to uphold safety, quality, and effectiveness across various industries, including pharmaceuticals, medical devices, food, and cosmetics. While our previous blog post, "Understanding FDA 21 CFR Part 11: Relevance for Your Organization," provided an in-depth analysis of the U.S. FDA 21 CFR Part 11, there are other important regulations to consider.
In this blog, we will introduce you to these regulators, direct you to further reading on them, and explain when they might be relevant to your business.
Section 1: Key GxP Regulatory Agencies
Let's take a quick look at some of the top GxP regulatory agencies around the world and the rules they set:
United States Food and Drug Administration (FDA): This federal, subordinate agency of the U.S. Department of Health and Human Services (HHS), is the regulatory arm for a multitude of sectors including food, drugs, medical devices, and cosmetics. They regulate manufacturers, distributers, relabelers, and repackagers, for both domestic and foreign establishments, who are involved with the production and distribution of these products intended for U.S. commercial distribution.
Link: https://www.fda.gov/
European Medicines Agency (EMA): In Europe, the EMA sets guidelines for Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). These rules match up with the International Council for Harmonisation (ICH) standards, which are harmonized worldwide.
Canadian Health Canada: This is the agency in charge of regulating drugs, biological products, and medical devices in Canada. Its GMP rules are part of the Canadian Drugs and Health Products regulations and are in line with ICH's GCP and GLP guidelines, similar to the U.S. FDA.
Australian Therapeutic Goods Administration (TGA): In Australia, the TGA looks after the regulation of therapeutic goods, including medicines, medical devices, and blood products in Australia. They use the Australian Code of Good Manufacturing Practice for medicinal products.
Link: https://www.tga.gov.au/
Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA): These Japanese agencies manage the regulation of pharmaceuticals and medical devices. Japan follows its own GMP, GCP, and GLP standards but aligns them with ICH guidelines.
World Health Organization (WHO): WHO sets globally recognized GxP guidelines, like GMP for pharmaceuticals, which serve as a guide for countries developing or improving their regulations.
Link: https://www.who.int/
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): Though not a regulator itself, ICH creates international standards, like ICH Q7 for GMP of Active Pharmaceutical Ingredients and ICH E6 for GCP, that regulatory agencies worldwide adopt.
Link: https://www.ich.org/
Pharmaceutical Inspection Co-operation Scheme (PIC/S): This group provides coordination between regulatory authorities around the world and provide recommendations and guidance for GMP of medicinal products for human or veterinary use. The approved guidance sometimes makes its way directly into the regulations and laws, verbatim.
United Kingdom Medicines & Healthcare Regulatory Agency (MHRA): The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
L'Agence nationale de sécurité du médicament et des produits de santé (ANSM): This group is responsible for the safety, efficacy and quality of drugs and medical products in France and provide guidance on GLP, GMP, GPP (Preparation/Dispensing) and GDP (Distribution).
Link: https://ansm.sante.fr/
Organisation for Economic Co-operation and Development (OECD): While not a regulatory agency, the OECD mandates member countries that non-clinical health and environmental safety testing, including laboratory testing involved with medical devices, is carried out according to the OECD Principles of GLP. Therefore, the OECD works with regulatory agencies around the world to perform regulatory inspections, audits, and provide compliance reports on GLP studies and certification to compliant laboratories.
China National Medical Products Administration (NMPA, formerly CFDA): The NMPA oversees drugs and medical devices in China, with GMP, GCP, and GLP regulations that are gradually becoming more in sync with international standards.
Each agency develops and maintains its own guidelines and rules, designed to fit their region's legal and regulatory needs. However, there's a big push towards making these rules more alike, especially through the ICH guidelines. This ultimately facilities the process of developing, approving, and monitoring pharmaceuticals and medical devices on a global scale.
Section 2: Data Integrity and Electronic Records Standards and Guidelines
Data integrity and the management of electronic records and signatures are crucial across the globe, similar to the standards set by the U.S. FDA's 21 CFR Part 11. These rules help ensure that electronic data and signatures are authentic, intact, and confidential. Below, you'll find a rundown of comparable standards or guidelines from various regulatory bodies:
U.S. Food and Drug Administration (U.S. FDA)
Data Integrity and Compliance With Drug CGMP, Questions and Answers, Guidance for Industry.
European Medicines Agency (EMA)
EudraLex Volume 4 Annex 11: Offers advice on the use of computerized systems within GxP-regulated environments in the European Union.
Guideline on computerised systems and electronic data in clinical trials.
Canadian Health Canada:
Good manufacturing practices guide for drug products (GUI-0001).
Australian Therapeutic Goods Administration (TGA):
PIC/S Guide to GMP for medicinal products – version 16: Adopts PIC/S guidelines, including standards for computerized systems, electronic records, and signatures, in line with international regulatory guidance.
Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA):
MHLW Ministerial Ordinance No. 169: Incorporates rules for electronic records and signatures within Japanese GMP regulations.
Ordinance on Standards for Electronic Record Management: Covers how electronic records should be managed during the regulatory submission and review processes.
World Health Organization (WHO):
Technical Report Series, No. 1033, Annex 4: Offers guidance on good data and record management practices, emphasizing the importance of data integrity within GxP settings.
International Council for Harmonisation (ICH):
While not setting specific regulations, ICH's guidelines, like ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System), stress data integrity as a crucial element of quality management. These guidelines are widely adopted by regulatory authorities in their own standards.
Pharmaceutical Inspection Co-operation Scheme (PIC/S):
GMP Guide (PE 009-17)
PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1)
United Kingdom Medicines & Healthcare Regulatory Agency (MHRA):
Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions
Parenteral Drug Association (PDA):
Technical Report No. 80 TR 80), Data Integrity Management System for Pharmaceutical Laboratories
Active Pharmaceutical Ingredients Committee (APIC):
APIC is a Sector Group within Cefic (European Chemical Industry Council). They provide guidance on quality related issues including data integrity:
China National Medical Products Administration (NMPA, formerly CFDA):
Good Manufacturing Practice (GMP) for Drugs: Features sections on electronic records and ensuring data integrity.
Data Integrity Guidelines (2017): Focuses on the specifics of maintaining data integrity in pharmaceutical manufacturing and testing.
Each GxP guideline underscores the critical importance of data integrity across the pharmaceutical, biotech, and medical device sectors, representing a global consensus on the necessity of reliable and accurate data management.
But...
Is a SaaS vendor working in the Life Science sector required to comply to all of these regulations?
For SaaS vendors operating in the life sciences, the question of compliance with all these regulations is not straightforward. Whether you need to adhere to every rule depends on several factors: the regions you serve, the nature of your clients, and the specific functionality of your software. It’s essential to evaluate your role in the regulatory landscape to ensure appropriate compliance.
In the next blog of this series, we’ll dive deeper into this question and cover topics like: What determines the need for compliance? Why is compliance important? And when might you not need to follow all the rules? We'll break it down to help you understand when compliance is required and when some exceptions might apply.
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