Pharma GMP News of the Week: 25-April-2023 Period: April 23, 2023 to May 20, 2023 Guidance from South Africa “Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH” Date of news: Apr 24, 2023 This guideline is meant to offer suggestions to applicants who seek to submit both new and modified registration applications. It …
Pharma-GMP-News
Pharma GMP News of the Week: 25-April-2023 Period: April 9, 2023 to April 22, 2023 FDA has published “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers” Date of news: April 12, 2023 This guidance offers details on risk-based methods for observing how clinical trials for human drugs, biologicals, medical devices, and combination …
Pharma GMP News of the Week: 13-April-2023 Period: April 2, 2023 to April 8, 2023 Japan’s PMDA published guidance on “System for reporting side effects and defects during clinical trials” Month of news: April 2023 It will be necessary to use the electronic application data system to submit reports of adverse medication reactions and flaws …
Pharma GMP News of the Week: 3-April-2023 Period: March 26, 2023 to April 1, 2023 PMDA, Japan published document on “Precautions for Cleaning and Disinfection of Gastrointestinal Endoscopes” Month of news: March 2023 The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has issued guidelines for cleaning and disinfecting gastrointestinal endoscopes in order to limit …
Pharma GMP News of the Week: 26-March-2023 Period: March 19, 2023 to March 25, 2023 ICH Published Introductory Training Presentation on The ICH Q9(R1) Date of news: March 20, 2023 In January 2023, the ICH Q9(R1) Guideline on Quality Risk Management reached Step 4 of the ICH Process. After the acceptance of this Guideline, the …
Pharma GMP News of the Week: 19-March-2023 Period: March 12, 2023 to March 18, 2023 News from EMA “EMA finalises guidance on computerised systems and electronic data in clinical trials” Date of news: March 9, 2023 The European Medicines Agency (EMA) has finalized a guideline on computerized systems and electronic data in clinical trials. This …
Pharma GMP News of the Week: 12-March-2023 Period: March 05, 2023 to March 11, 2023 FDA published “Guidance for Industry: Labeling of Infant Formula” Date of news: March 6, 2023 The Food and Drug Administration is issuing this reminder to infant formula makers and distributors (“you”) about certain infant formula labelling requirements. While this guidance …
Pharma GMP News of the Week: 5-March-2023 Period: February 26, 2023 to March 4, 2023 News from EDQM “The future of pyrogenicity testing: new approaches discussed at joint EDQM-EPAA event” Date of news: February 27, 2023 For certain high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove …
Pharma GMP News of the Week: 26-February-2023 Period: February 19, 2023 to February 25, 2023 EMA published “Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR)” Date of news: February 9, 2023 With the purpose of guiding sponsors through the Clinical Trials Regulation (CTR) and the new clinical trials information …
Pharma GMP News of the Week: 19-February-2023 Period: February 12, 2023 to February 18, 2023 MHRA Inspectorate Blog published 25+ Frequently Asked Questions on related to “Manufacture of Investigational Medicinal Products” Date of news: February 3, 2023 MHRA Clinical Trials and GMP and GCP Inspectors collaborate closely, and they frequently offer assistance in response to …
