Last weeks’ round -up;
01-12 November 2021

published 15 Nov 2021

FDA releases 48 new and updated product-specific guidances

The FDA has released 48 new or updated product-specific guidances (PSG) as well as a newly developed infographic that provides a snapshot of the overall PSG program. The new draft PSGs include guidances to aid in the development of generics for the malaria treatment artesunate, the non-statin cholesterol lowering drug bempedoic acid, small cell lung cancer therapy lurbinectedin, the cholangiocarcinoma treatment pemigatinib, and migraine drug rimegepant sulfate, among other reference listed medicines. The FDA’s webpage on upcoming PSGs for complex generic drug product development has also been updated, with the agency’s progress in meeting its commitments under the reauthorization of the Generic Drug User Fee Amendments (GDUFA II).

PDG signs-off on milestone harmonised general chapter on chromatography

On the 28th September 2021, the Pharmacopoeial Discussion Group (PDG) signed off the harmonised general chapter on Chromatography, which brings together the Ph. Eur., JP and the USP texts. The chapter contains harmonised requirements which promote the development of individual monographs with a consistent approach and enhance understanding of basic requirements by users in all three regions. Particular attention was paid to:

· Terminology, definitions and interpretation of chromatograms.

· System suitability: this section provides requirements intended to guarantee that the performance of the chromatographic system is appropriate. They apply to multiple monographs and are to be read in conjunction with the requirements described therein.

· Adjustment of chromatographic conditions.

· Quantitation procedures.

MDCG issues new Q &A document regarding repackaging and relabelling of medical devices

MDCG 2021-26 Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

FDA: Nitrosamine detection tests should be ‘fit for purpose’

The US FDA has advised manufacturers that analytical tests used for the detection of nitrosamines should be “fit for purpose” in order to ensure that the right test is measuring the right impurity. The Agency has also advised that orthogonal (additional) methods should be used to double-check results. Nitrosamine contamination can be process-related, the impurities may be introduced via the supply chain or formed over the shelf-life of the drug product. The RAPS article below describes various case studies highlighting the importance of cross-checking and using analytical methods that are fit for purpose while conducting nitrosamine risk assessments.

Medical Device Coordination Group issues new guidance for legacy devices

MDCG 2021-25 Application of MDR requirements to “legacy devices” and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC

Revised ICH guideline on general considerations for clinical trials, ICH E8(R1)

The revised ICH guideline on general considerations for clinical trials [ICH E8(R1)] has been adopted by the Committee for Human Medicinal Products and will come into effect on 14th April 2022. This is the first time the guideline has been revised since its original adoption in 1997, and its update is being considered the “first step towards the Renovation of Good Clinical Practice initiated in 2017”. The revised guideline adopts quality-by-design principles and highlights fit-for-purpose data quality as one of the essential considerations for all clinical trials. Main updates identified from the previous version are a basic set of critical-to-quality factors that can be adapted to different trials, incorporation of a broader range of trial designs and data sources, and an updated cross-referencing of all other relevant ICH Guidelines that should be referred to when planning clinical studies. 

Search Real Regulatory