Pharma-GMP-News

Pharma GMP News of the Week: 5-February-2023 Period: January 29, 2023 to February 4, 2023 In-person formal meetings with the FDA will resume in February. Date of news: January 30, 2023 Source: https://www.fda.gov/industry/prescription-drug-user-fee-amendments/update-person-face-face-formal-meetings-fda?utm_medium=email&utm_source=govdelivery  News from EDQM – CEP holders – How to submit a nitrosamine risk assessment Date of news: January 30, 2023 The European …

Pharma GMP News of the Week February 5, 2023 Read More »

Pharma GMP News of the Week: 29-January-2023 Period: January 22, 2023 to January 28, 2023 News from EMA “Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications” Date of news: January 19, 2023 The usage of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications …

Pharma GMP News of the Week January 29, 2023 Read More »

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 …

Pharma GMP News of the Week January 22, 2023 Read More »

Pharma GMP News of the Week: 15-January-2023 Period: January 8, 2023 to January 14, 2023 The Medical Device Coordination Group (MDCG) has published guidance on the application of the medtech legislation to devices and diagnostics produced and used by healthcare organisations in the European Union. Month of news: January 2023 The majority of the article …

Pharma GMP News of the Week January 15, 2023 Read More »

Pharma GMP News of the Week: 8-January-2023 Period: January 1, 2023 to January 7, 2023 The Central Drugs Standard Control Organization (CDSCO) requested that human vaccination firms submit summaries of their “established” pharmacovigilance systems Month of News: December 2022 The New Drugs and Clinical Trials Rules, 2019 require each new medication imported or manufactured in …

Pharma GMP News of the Week January 8, 2023 Read More »

Consolidated List of ICH Guidelines and Updates Published in 2022 Period: January 2022 to December 2022 The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international organization that develops guidelines to help ensure the quality, safety, and effectiveness of pharmaceutical products. These guidelines are used by pharmaceutical industry …

List of ICH Guidelines published in 2022 Read More »

Consolidated List of MHRA Guidelines and Updates Published in 2022 Period: January 2022 to December 2022 The MHRA (Medicines and Healthcare products Regulatory Agency) is a UK government agency responsible for ensuring that medicines and medical devices meet safety standards. The MHRA publishes guidelines on a range of topics related to the pharmaceutical industry, including …

List of MHRA Guidelines published in 2022 Read More »

Consolidated List of US FDA Guidelines Published in 2022 Period: January 2022 to December 2022 The U.S. Food and Drug Administration (FDA) is a federal agency that is responsible for protecting and promoting public health through the regulation of drugs, medical devices, and other products. The FDA has established a set of guidelines that pharmaceutical …

List of US FDA Guidelines published in 2022 Read More »

Pharma GMP News of the Week: 25-December-2022 Period: December 18, 2022 to December 24, 2022 EU Published guidance “EU Guideline on orphan applications (for designation and transfer) – 2022/C 440/02” Date of news: December 19, 2022 This guideline provides further guidance on the information sponsors must supply when seeking for orphan medicinal product designation. It …

Pharma GMP News of the Week December 25, 2022 Read More »

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 …

Pharma GMP News of the Week December 18, 2022 Read More »

Scroll to Top
Scroll to Top