Laws are alive. They are constantly changing. I’ve found in more than one occasion that auditees has obsolete regulatory books and, therefore, their Quality System has not been updated.
We are in the Century 21th. And it’s easy and free to Access to information via Internet. Pharma companies should not invest a big amount of money to have their regulatory information updated. I’d like to help you with some links with relevant information for pharma companies::
- MHRA blog: https://mhrainspectorate.blog.gov.uk
- European Comission website: http://ec.europa.eu/health/documents/eudralex/index_en.htm
- FDA website: http://www.fda.gov/
- AEMPS website (Spain): http://www.aemps.gob.es/
- ECA GMP news: http://www.gmp-compliance.org/eca_news_liste_2015.html
- Ansm website (France): http://ansm.sante.fr/S-informer/Actualite
- PEI (Ireland): http://www.pei.ie/Sitewide-News/Current-News
- AGES (Austria): http://www.ages.at/en/startseite/
- CFDA (China): http://eng.sfda.gov.cn/WS03/CL0755/
- TGA (Australia): https://www.tga.gov.au/latest-news-updates
- Canadá: http://www.hc-sc.gc.ca/index-eng.php
- PIC/S: http://www.picscheme.org/news.php
- WHO: http://www.who.int/en/
I hope you found it interesting and useful. If it is, please share it with your contacts.
Thank you very much.