Search This Blog

Sunday, October 10, 2010

Regulators are sharing more and more information through the agreements between them

As per the two recently signed confidentiality agreements we can know how the regulators are thinking on the future aspects. In both agreements, the partners have provided assurance that they can effectively protect this non-public information.

On September 15, 2010 EMA and FDA formally extended their existing confidentiality agreements for an indefinite period. This agreement allows sharing of inspection reports and other non-public information between the agencies.

On September 24, 2010, FDA and ANVISA signed a confidentiality agreement that permits sharing of non-public information. This is the first confidentiality agreement between the two regulatory agencies, and acknowledges Brazil’s rising importance as a pharmaceutical market and supplier and ANVISAs rise as a regulatory agency.

To read the agreements between agencies write to me i will be sending you the same agreements

No comments:

Post a Comment