Quality Systems

Articles

A recently published European Medicines Agency (EMA) report has demonstrated that there are continued efforts being made across Europe to reduce the amount of antibiotics used in animals.

EMA Report Shows Continued Efforts by European Countries to Reduce Antibiotic Use in Animals

As the world awaits the outcome of Brexit, a presentation taking place at CPhI Worldwide in Frankfurt, Germany will delve deeper into the implications of each potential scenario on the pharma industry.

Deal or No Deal? Tackling the Implications of Brexit on Pharma

Glenmark Pharmaceuticals has been granted marketing approval from the Russian Ministry of Healthcare for its film-coated tablets, Montlezir, to treat seasonal and perennial allergic rhinitis.


Glenmark Gets Nod to Market Montlezir in Russia

Sean Milmo is a freelance writer based in Essex, UK.

A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office. 

Out with the Old and In with the New European Commission

Dr. Jeremy Drummond is senior vice-president of business development for MedPharm.

Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.

Getting in Touch with New Guidance on Topical Products

The European Commission has approved the first plant-derived cannabis-based medicine for the treatment of seizures in patients suffering from two rare, severe forms of childhood-onset epilepsy.

EC Approves Plant-Derived Cannabis-Based Medicine to Treat Epileptic Seizures

Regulatory agencies published guidelines to advance drug development, streamline submission processes, and promote biosimilars. 

What’s New in Regulations and Compliance

A request has been made to the CHMP by the executive director of EMA to provide guidance on how to avoid the presence of nitrosamine impurities in human medicines.

EMA Provides Guidance on How to Avoid Nitrosamines in Human Medicines

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

This article examines the history and evolution of the pharmacopoeias and the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias.

A Brief History of Pharmacopoeias: A Global Perspective (PDF)

The authors take a closer look at these ongoing efforts to harmonize compendial standards, with perspective that may be helpful in considering the future direction of pharmacopoeias.

Regulatory/GMP Compliance, Europe