To track regulatory compliance trends in the US FDA, European Union (EU), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Pharmaceutical Inspection Co-operation Scheme (PIC/s), and Good Automated Manufacturing Practice (GAMP), here are some useful resources:
US FDA:
- FDA website: The official website of the US Food and Drug Administration provides comprehensive information on regulations, compliance guidance, and news related to FDA-regulated products. Visit their website at www.fda.gov.
- FDA Newsroom: The FDA Newsroom offers the latest news releases, updates, and announcements from the FDA. You can access it at www.fda.gov/news-events.
- FDA's Electronic Submissions Gateway (ESG): The ESG allows you to track electronic submissions, including regulatory filings and communications, with the FDA. You can find more information about it on the FDA's website.
- FDA Data Dashboard. https://datadashboard.fda.gov/ora/cd/inspections.htm
- The FDA has created the Data Dashboard to increase transparency and accountability by displaying and allowing the analysis of public FDA data through easy to use, visually accessible, customizable, and understandable graphics.
European Union (EU):
- European Medicines Agency (EMA): The EMA is responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union. Their website (www.ema.europa.eu) provides information on regulations, guidelines, news, and updates related to medicinal products.
- European Commission: The European Commission's website (ec.europa.eu) offers information on regulations, directives, and guidelines related to various industries, including pharmaceuticals, medical devices, and food supplements. You can search for specific regulations or browse the relevant sections.
- EU Official Journal: The EU Official Journal publishes legal acts, directives, regulations, and other important documents related to EU legislation. You can access it online at https://eur-lex.europa.eu/oj/direct-access.html.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH):
- ICH website: The official website of ICH (www.ich.org) provides information on international standards and guidelines for the development, registration, and post-approval of pharmaceutical products. You can find guidelines, reports, and other resources related to regulatory compliance trends.
Pharmaceutical Inspection Co-operation Scheme (PIC/s):
- PIC/s website: PIC/s is an international organization that promotes good manufacturing practices (GMP) in the pharmaceutical industry. Their website (www.picscheme.org) provides access to PIC/s guides, news, and information on regulatory compliance.
Good Automated Manufacturing Practice (GAMP):
- International Society for Pharmaceutical Engineering (ISPE): ISPE's GAMP website (www.ispe.org/gamp) offers resources, publications, and events related to GAMP, which provides guidelines and best practices for the validation and use of automated systems in the pharmaceutical industry.
Regulatory News and Industry Publications:
- Regulatory Focus: Regulatory Focus is a publication by the Regulatory Affairs Professionals Society (RAPS) that covers global regulatory news and trends, including updates from the FDA, EU, ICH, and other regulatory bodies. You can find it at www.raps.org/regulatory-focus.
- Pharma Intelligence: Pharma Intelligence, formerly known as Informa Pharma Intelligence, provides industry news, analysis, and insights on regulatory affairs, including coverage of FDA, EU, ICH, and other regulatory developments. Visit their website at www.pharmaintelligence.informa.com.
These resources should help you track current regulatory compliance trends. Stay updated by regularly visiting their websites, subscribing to newsletters, and following industry publications.
If you wish to prepare yourselves and for an US FDA/EU inspection to avoid Warning Letters on computerized system compliance and data integrity, we have training programs with focus on the current trends in FDA/EU inspections and GAMP guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Please contact us at [email protected]
US FDA Definitions:
Form 483:
- Notifies management at the conclusion of an inspection of objectionable conditions
- Does not constitute a final Agency determination
- Companies are encouraged to respond
Warning Letters
- Sent by FDA to advise of violations
- Request written response as to steps taken to address violation
Seizure
- Action brought against product that is adulterated and/or misbranded
- Removes violating products from commerce
Injunction
- Court-ordered
- May be sought by FDA to require an individual or corporation to do or refrain from doing a specific act
Criminal Prosecution & Fines
- May recommend prosecution for certain violations
- Fines ranging from $100k-500k; imprisonment for up to 1 year
