Pharma GMP News of the Week December 18, 2022

Pharma GMP News of the Week: 18-December-2022

Period: December 11, 2022 to December 17, 2022

The European Commission takes action to streamline EMA fee regulations

Date of news: December 13, 2022

The European Medicines Agency charges fees, and the Commission is now proposing to modernise and simplify the law governing those payments. The major goal is to make sure that these fees more accurately represent the true expenses of the services completed and managed by EMA.

Companies must pay EMA a charge for the agency’s evaluation when they submit a request for a marketing authorization for a drug. The compensation that EMA gave to national authorities participating in the evaluation is also included in this price. To ensure that the fees more accurately represent the necessary expenditures, the Commission’s proposal updates the whole EMA charge structure. A cost-monitoring system and more latitude for adjusting rates in response to large changes in costs. 

Source: Pharmaceuticals: Commission proposes updated EMA fees

Safety and data integrity are significant considerations in the EMA’s published recommendations for conducting decentralised trials

Date of news: December 13, 2022

Electronic diaries, wearables, phone conversations, and online appointments are just a few of the decentralised components that clinical trials for medical items have already incorporated. The agencies stated in a recommendation paper released on December 13, 2022 that the proper use of these components depends on the type of clinical trial, the trial population, the disease being treated, the trial participant’s condition, the type of medical product, as well as the product’s characteristics and stage of development.

Source: RECOMMENDATION PAPER ON DECENTRALISED ELEMENTS IN CLINICAL TRIALS 

FDA Published final guidance on “Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry”

Date of news: December 14, 2022

This guideline is designed to help applicants of ANDAs submitted under section 505(j) of the Federal FD&C Act (21 U.S.C. 355(j)) reply to FDA complete response letters (CRLs). ANDA applicants are obligated by rule to take action after obtaining a CRL. The guideline updates the guidance given in July 2022 with the same title. The purpose of this change is to include the performance objectives established in the Generic Drug User Fee Amendments. Performance Goals and Program Enhancements for Fiscal Years 2023-2027. This advice includes information and suggestions on various courses of action for an ANDA application following the release of a CRL, as well as measures that the FDA may take if the applicant fails to react to the CRL.

Source: Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

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News from EDQM: Signal-to-noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques (2.2.46)

Date of news: December 14, 2022

In the interests of global standardisation, the updated general chapter Chromatographic separation techniques (2.2.46) was included in the 11th Edition of the European Pharmacopoeia (Ph. Eur.). This updated version, which will go into effect on January 1, 2023, has several significant modifications.

The sensitivity requirement is one of these adjustments. Unlike from Ph. Eur. Supplement 6.4 through Supplement 10.8, where it is calculated on a window of at least 5 times the peak width at half height (“at least 5 x Wh”), the revised chapter instructs users to calculate the signal-to-noise (S/N) ratio on a window of 20 times the peak width at half height (“20 x Wh”).

The Ph. Eur. Commission had to examine this adjustment in light of recent data received by the European Directorate for the Quality of Medicines & Healthcare (EDQM) that suggested some of our users would find it technically difficult.

So, instead of using “20 x Wh,” Ph. Eur. users are urged to continue computing the S/N ratio on a window that is “at least 5 x Wh.”

The updated version of General Chapter 2.2.46 will be included in Supplement 11.3 (to be published in July 2023 and implemented on 1 January 2024).

Source: https://www.edqm.eu/en/-/signal-to-noise-ratio-revision-of-ph.-eur.-general-chapter-chromatographic-separation-techniques-2.2.46- 

FDA Published draft guidance on “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (December 2022)”

Date of news: December 15, 2022

A draught of a guideline document titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection” is now available, according to the Food and Drug Administration (FDA or Agency). The Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended by the FDA Reauthorization Act of 2017 (FDARA), and as a result, a device is now considered adulterated if the owner, manager, or agent of the factory, warehouse, or establishment where it is made, processed, packed, or stored delays, refuses, or restricts an FDA inspection.

The sorts of behaviours (actions, inactions, and situations) that the FDA regards to constitute delaying, denying, or restricting inspection, or refusing to authorise entrance or inspection, are described in this draught advice for both pharmaceuticals and, as of today, devices. This draught guideline is meant to replace the FDA’s final industry guidance from October 2014, “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” once it has been completed. The FDA guideline from October 2014 is still in force until it is withdrawn and will continue to represent FDA’s current thinking on this matter until this draught guidance is finalised. Comments on the addition of devices to the October 2014 guidelines are of special relevance to FDA.

Source: https://www.fda.gov/media/163927/download 

EDQM releases new edition of the Tissue and Cells Guide, providing state-of-the-art guidance for healthcare professionals

Date of news: December 15, 2022

The 5th version of the Guide to the Quality and Safety of Tissues and Cells for Human Application has just been released by the European Directorate for the Quality of Medicines & Healthcare (EDQM). With regard to assuring the quality and safety of human tissues and cells used on patients, the revised handbook offers a thorough review of the most current developments in the area. It is designed for medical professionals who are involved in all phases of the pertinent activities, from finding suitable donors to using it clinically on patients and monitoring their progress.

Source: EDQM releases new edition of the Tissue and Cells Guide, providing state-of-the-art guidance for healthcare professionals

EMA published highlights of December 2022 meeting of Management Board

Date of news: December 16, 2022

Key highlights of the meeting are on the following topics;

1. The 2023 budget and EMA multiannual programming.

2. The Clinical Trials Regulation’s implementation.

3. The regulation governing veterinary medicinal products is put into effect.

4. Report of the Committee on Advanced Therapies.

5. Audit plan 2023 and audit approach 2023–2025.

Source: EMA Management Board: highlights of December 2022 meeting | European Medicines Agency

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