REGULATORY UPDATES | NAME OF THE REGULATORY AGENCY

REGULATORY UPDATES

SR. NO.	NAME OF THE REGULATORY AGENCY	WEBSITES
1	DCGI (India)	www.cdsco.nic.in
2	WHO	www.who.int
3	ICH	www.ich.org
4	PICs	www.picscheme.org
5	USFDA	www.fda.gov/drugs
6	Health Canada (Canada)	www.hc-sc.gc.ca
7	MHRA (Europe)	www.mhra.gov.uk
8	EMEA (Europe)	www.ema.europa.eu
9	EDQM (Europe)	www.edqm.eu
10	MCC (South Africa)	www.mccza.com
11	TGA (Australia)	www.tga.gov.au
12	ANVISA	www.anvisa.gov.br/eng/index.htm

Head –QA/designee shall subscribe to receive the periodic updates and changes of regulatory guidance from various regulatory agencies at the following web addresses, where such subscription is not available, specific website shall be checked for any updates.

Regulatory guidance updates shall be reviewed and downloaded by visiting the web sites mentioned above. Latest regulatory guidance/addendum to guidance can be downloaded from publications/news centers/consumer updates/public health notifications/latest press etc.

Head QA/designee shall compile the updates and relevant changes and communicate to all affecting departments once in a month

RA, R&D, Marketing and Purchase departments shall also be informed by Head-QA for the regulatory updates/relevant changes,

After receiving news letter/updates/information from QA, all affecting departments head shall evaluate the system by performing gap analysis against the updated guidance