Pharma GMP News of the Week January 22, 2023

Pharma GMP News of the Week: 22-January-2023

Period: January 15, 2023 to January 21, 2023

FDA has published draft “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases”

Date of news: January 17, 2023

This guidance is intended to assist sponsors in determining the best dosage(s) for human prescription medicines or biological products in clinical development for the treatment of oncologic illnesses prior to filing an application for approval for a new indication and usage. This guidance does not cover dosage optimization for radiopharmaceuticals, cellular and gene therapy products, microbiota, or cancer vaccines, nor does it address dosage selection for first-in-human trials.

Source: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases 

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MHRA Press release “MHRA increases UK assessment capacity for in-vitro diagnostic devices”

Date of news: January 18, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that UL International UK Ltd has been designated to assess the majority of in-vitro diagnostic (IVD) devices, increasing the UK’s capacity to process conformity assessments and ensure safe and effective IVDs reach the UK public.

Source: MHRA increases UK assessment capacity for in-vitro diagnostic devices – GOV.UK 

MHRA has updated information on how to submit the SAE reporting form

Date of news: January 18, 2023

Source: Notify the MHRA about a clinical investigation for a medical device – GOV.UK 

EDQM has rolled out user satisfaction survey for review on revamped EDQM website

Date of news: January 18, 2023

Over nine months ago, on 1 April 2022, the European Directorate for the Quality of Medicines and HealthCare (EDQM) launched its new website. You’ve had time to explore what the new website has to offer, therefore the EDQM is looking for your input via an anonymous customer satisfaction survey. Visit the following link to participate in the survey.

Source: https://www.edqm.eu/en/-/user-satisfaction-survey-revamped-edqm-website 

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News from EDQM “Call for experts – Aluminium in parenteral nutrition solutions”

Date of news: January 19, 2023

Although several European countries control aluminium in parenteral nutrition solutions (PNS), there are currently no European rules restricting the maximum amount of aluminium in these solutions, which are frequently manufactured on the spot. To address this issue, the European Pharmacopoeia (Ph. Eur.) is looking for qualified professionals with experience in PNS and parenteral preparations, particularly those with experience in quality and toxicological assessment of aluminium content, to join the newly formed Aluminium in Parenteral Solutions Working Party (ALU WP). This WP will be in charge of creating a new general chapter on aluminium in parenteral nutrition solutions in order to reduce the danger of exposure to harmful levels of aluminium. The document is also expected to provide instructions for individuals who will prepare and administer these solutions.

Source: https://www.edqm.eu/en/-/call-for-experts-aluminium-in-parenteral-nutrition-solutions 

FDA has published draft “Mpox: Development of Drugs and Biological Products; Guidance for Industry”

Date of news: January 19, 2023

The FDA is publishing this guidance to assist sponsors in developing drugs for mpox. This document includes nonclinical, virology, and clinical considerations for mpox medication development initiatives, with a focus on suggestions to assist clinical trial commencement.

Source: https://www.fda.gov/media/164642/download 

FDA has published “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act”

Date of news: January 19, 2023

Source: https://www.fda.gov/media/164693/download 

News from EDQM “Supplement 11.2 of the European Pharmacopoeia (Ph. Eur.) is now available”

Date of news: January 20, 2023

Source: Implementation of the European Pharmacopoeia Supplement 11.2 – Notification for CEP holders 

News from ICH “The ICH Q9(R1) Guideline reaches Step 4 of the ICH Process”

Date of news: January 20, 2023

This Guideline is intended to provide direction on the principles of quality risk management and examples of methods that can be applied to various elements of pharmaceutical quality.

Development, manufacturing, distribution, and the inspection and submission/review processes for drug substances, drug (medicinal) products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging, and labelling materials in drug (medicinal) products, biological and biotechnological products) are all included.

Source: https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2022_1219.pdf 

The US Food and Drug Administration adopted a final regulation that drastically cuts record-keeping requirements for medical devices like x-rays.

Date of news: January 20, 2023

The Food and Drug Administration (FDA, Agency, or we) is amending and repealing portions of the radiological health regulations that cover recommendations for radiation protection during medical procedures, certain electronic product records and reporting, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The Agency is taking this action to clarify and update regulations in order to remove outmoded regulatory requirements that duplicate other measures of protecting public health from dangerous exposure to radiation emitting electronic gadgets and medical devices.

Source: Federal Register :: Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products 

MDCG issues recommendations on notified body postings of standard MDR and IVDR Fees

Date of news: January 2023

MDCG has issued guidance on how notified entities can meet the requirement to publish their rates for medtech regulatory services.

Source: MDCG 2023-2 List of standard fees

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