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Update on ICH Q9(R1) Quality Risk Management Muhammad Asim Niazi
August 23, 2023
In collaboration with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – ICH, the FDA has updated the 2006 version of Q9 Quality Risk Management.
AHA News: Dangerous Bleeding Strokes Disproportionately Affect Asian American, Pacific Islander Adults drugs.com
February 08, 2022
Asian and Pacific Islander adults in the U.S. are disproportionately affected by a deadly type of stroke that causes bleeding into the brain...
LGM Pharma Launches Analytical Services for Drug Developers and Manufacturers contractpharma
July 09, 2021
LGM Pharma has launched its new Analytical Services offering that provides analytical testing and stability services to pharmaceutical developers and manufacturers, including compounding pharmacies.
New harmonised guidance for post-approval changes released by FDA europeanpharmaceuticalreview
May 18, 2021
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products americanpharmaceuticalreview
May 14, 2021
The U.S. Food and Drug Administration is announcing the availability of a final guidance for industry, “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.”
Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--EU zhulikou431
October 11, 2018
The EU has been early in conducting PV, and possesses a sound PV system which is also divided into three layers for regulation: directives, regulations, and guidelines. See the following table for the main establishment process of regulations of the EU PV
Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--U.S. zhulikou431
September 28, 2018
In early September 2018, the National Medical Products Administration of China (NMPA) consecutively released announcements on revision of package inserts of four (varieties of) pharmaceutical products.
New biopharmaceutical testing laboratory to open in Geneva cphi-online
August 29, 2018
SGS's expansion will enable the service provider to offer a full ICH Q6B physico-chemical characterization of biological products.
Gaining the Initiative! SDA Becoming an ICH “Administrator” Muzi
June 27, 2018
In the 2018 first meeting of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) held in Kobe, Japan, SDA was absorbed as a member of ICH Management Committee.
ICH flooded the screen, China’s joining of ICH not officially recognized yet en-cphi.cn
June 09, 2017
It has been reported early in the morning of June 2 that CFDA was voted to formally become a full member of ICH at the venue in Montreal, Canada.