Quality Systems

Articles

Propess (dinoprostone) from Ferring Pharmaceuticals has achieved approval from the Minister of Health, Labour, and Welfare (MHLW) in Japan, making it the first pharmacological treatment for cervical ripening to be approved in the country for more than 20 years.

Pharmacological Treatment for Cervical Ripening Gains Approval in Japan

As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced. 

EMA Approves Production Facility for Pharming’s Lead Product

The drug treats adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity. 

Novartis Announces EC Approval of MS Drug

The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.

EMA Evolves Approach to Data Use

Inflazome, a biotech company based in Dublin, Ireland, has announced that the United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO) will grant its patent applications in January 2020.


Inflazome to be Granted Patents in US and Europe

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

In 2020, European regulators are expected to start to be even more active in encouraging drugs innovations rather than hindering them through legal restrictions.


European Regulators Strive to Make Up for Lost Ground

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.

Pharma’s Decade in Brief

Regulatory mandates, niche diseases, and patient-centric solutions have all impacted pharma packaging over the years and are expected to help shape the future of the sector.


On Trend in Pharma Packaging

Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market.


Devices Under Scrutiny

The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.

Regulatory/GMP Compliance, Europe