The EMA published an updated Q&A document regarding the new ICH M10 guideline on Bioanalytical Method Validation and Study Sample Analysis. The document became effective on 21 January 2023.
In the Pharmacopeial Forum, PF 49(1), a proposal for a revised USP General Chapter <1236> Solubility Measurements was published. Based on comments received, some revisions were made in addition to those proposed in PF 48(2).
As recently reported, the "ICH guideline Q3C (R8) on impurities: guideline for residual solvents)" has been updated and can be consulted on the ICH website under the section "Quality Guidelines". As a result, the USP chapter "<467> Residual Solvents" has now been revised and published for comment on the USP Pharmacopeial Forum website.
Australias Therapeutic Goods Administration (TGA), which regulates Medicinal Cannabis in Australia, has put out its latest Compilation regarding the production and import regulations (TGO 93). As of July 2023, all imported medicinal cannabis products released for supply in Australia will have to present evidence to be produced under GMP.
The Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", which was jointly prepared by the EMA and the CMDh, has been updated and the latest version published on the EMA website.
Already in 2018, the ICH had started working on a Guideline entitled "CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS - Q13". A draft was published in mid-2021. Now ICH has approved the final version.
With ICH Q9 Quality Risk Management becoming effective, risk analyses have become the "magic word" in the GMP environment. But risk analyses do not always help. An example of this can be found in an FDA Warning Letter on the subject of cross-contamination.
In December 2022, the "Questions & Answers (Q&A)" documents relating to centralised marketing authorisation procedures were again revised and published on the website of the European Medicines Agency (EMA). The Q&A catalogues, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to possible questions at the different stages of the centralised marketing authorisation application process.
In December 2022, the US-American FDA published the draft of the so-called document entitled "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions" for comment. This is the second revision of the guidance document, which has been in place since 2017. It is now open for comment until 07 March 2023.
The "IRIS guide to registration and RPIs" was updated again between the end of November and mid-December 2022. The "IRIS guide for applicants" has also been revised and is now valid as version 2.13. The latest versions of both documents are available on the EMA website.