ISO 14644-21 is released
The newly published ISO 14644 part 21 provides clarification on the application of sound airborne particle sampling techniques in support of ISO...
The newly published ISO 14644 part 21 provides clarification on the application of sound airborne particle sampling techniques in support of ISO...
Yesterday, 27 September 2023, the Manual on limits and classification in the community regulatory framework for medical devices was published...
The Regulation (EU) 1545/2023 of the commission of 26 July 2023 which modifies the Reg. 1223/2009 (EC) of the European Parliament and of the Council...
AIFA has published the attached document relating to the object"Following the requests for clarification received, information is provided in this...
3On 1/03/2023, the “Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 which amends regulation (EC) no. 1272/2008 as regards the...
Companies are advised that, from 1 April 2023, the rates contained in Annex 1 of the D.M. 6 December 2016, concerning "Update of current tariffs and...
Draft: WHO good manufacturing practices for excipients used in pharmaceutical 7 products.
Please note that all pharmaceutical companies must submit to the Italian Medicines Agency by and no later than 30 April 2023 the self-certification...
This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of...