Regulatory/GMP Compliance, Europe

No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

EU regulators have accelerated their efforts to use the mass of data emerging from the lifecycles of drugs as an effective basis for both the development and control of medicines.

Kyowa Kirin has announced that its treatment for X-linked hypophosphatemia (XLH), Crysvita (burisumab), has been approved by Swissmedic for use in adults, adolescents, and children (1 year and older).

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.

The European Commission (EC) has approved Pfizer’s treatment for wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), Vyndaqel (tafamidis).

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that the use of cyproterone be restricted as a result of the potential risk of meningioma.

ERS Genomics revealed that the European Patent Office (EPO) has rejected arguments filed in opposition to patent EP2800811, which is directed to the single-guide CRISPR/Cas9 gene editing system and covers uses in cellular and non-cellular settings.

The National Institute for Health and Care Excellence (NICE) has issued guidance in Feb. 2020 stating that it does not recommend the combination therapy of pembrolizumab with axitinib for the treatment of advanced renal cell carcinoma in adults.

ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

The UK and Europe are entering a transitional period, which will involve negotiations across the board, including those on the pharma regulatory landscape.

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended that Givlaari (givosiran) be granted marketing authorization in the European Union.

The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.

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.

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.

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

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.

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.

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

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.

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.

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

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.

The revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world are described.

This article describes the revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world.

An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.

An understanding of global and national pharmacopoeias is crucial to understanding change processes and access to different markets.

The process used to monitor and participate in pharmacopoeial changes is described.

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.