European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices.

Method Validation 98

Method Validation Documentation FDA 98

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

AUGUST 29, 2022

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. Trudy Patterson. Cauchon, PhD.

Documentation 52

Documentation FDA Communication Packaging 52