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New regulations in the Year 2023 for different regulatory bodies around the world Muhammad Asim Niazi
January 23, 2024
This article will explore new regulations in countries like the United States, Europe, Japan, and Australia.
EMA regulation and response to drug shortages PharmaSources/zhulikou431
June 12, 2023
The EMA has established an agency called the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address drug shortages.
Why Drug regulatory authority updates their Rules and Regulations Muhammad Asim Niazi
March 21, 2023
Pharmaceutical regulatory authorities regularly update their rules and regulations regarding drug review and approval.
Pharma Co-packaging Regulations Muhammad Asim Niazi
March 21, 2023
Let’s discuss some regulatory requirements for contract packaging in line with three most competitive markets i.e China , United States and Europe.
Drug Marketing in China and Worldwide (July) Caicai/PharmaSources
August 11, 2023
On July 6th, Eisai's lecanemab (Leqembi) was fully approved by the FDA for the treatment of Alzheimer's disease
Biosimilars 2020: Low Approvals, but Significant Advances Neeta Ratanghayra
March 18, 2021
2020 has been a tough year. The pandemic posed an array of challenges to the healthcare system and the global biopharmaceutical industry both rose to the challenges and seized opportunities.
New regulation strengthens role of EMA in EU crisis response EuropeanPharmaceuticalReview
February 09, 2022
NEWS New regulation strengthens role of EMA in EU crisis response The regulation sees tools, structures and processes set up by EMA during the pandemic to accelerate clinical trial approval and regulatory assessments in the EU being formally recognised.
Drugmakers Meet With EMA on Vaccines Targeting Omicron FirstWordPharma
January 11, 2022
The European Medicines Agency (EMA) is meeting with four leading COVID-19 vaccine makers to discuss potential trials for shots targeting the fast-spreading Omicron variant, as reported in the Financial Post.
Pfizer’s Paxlovid™ can be used for the treatment of COVID-19, says EMA EuropeanPharmaceuticalReview
December 21, 2021
New European Medicines Agency advice states Paxlovid™ can be used to treat those at high risk of developing severe COVID-19 symptoms.
EMA CHMP advises use of Pfizer’s Covid-19 oral antiviral Paxlovid Pharmaceutical-Technology
December 20, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the usage of Pfizer’s oral antiviral, Paxlovid (nirmatrelvir plus ritonavir), to treat adult Covid-19 patients.

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