Regulatory Oversight

The European Medicines Agency has announced that its physical relocation to Amsterdam will be complete in March 2019.

The Wasdell Group has been granted a Health Products Regulatory Authority (HPRA) license for its new European headquarters, based in Dundalk, Ireland.

The company is voluntarily recalling six lots of Losartan potassium and hydrochlorothiazide tablets, USP because of the impurity, NDEA.

The EU FMD deadline is closing in, so now is the time to look beyond the short term.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has made two significant changes to its new 2019 Code of Practice with the aim of boosting business integrity on a global scale.

The revised guidance aims to strengthen the agency’s global approach to develop new antibacterial medicines.

The plan details five goals to guide the development of Sentinel, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, over the next five years.

The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.

In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.

FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.

This year promises to bring more focus on risk management and building a quality culture, says consultant Susan Schniepp.

Understanding the differences in inspection processes is the key to successful global expansion, according to Siegfried Schmitt, PhD, vice-president Technical, PAREXEL Consulting.

FDA plans to support initiatives to ensure that all medicines are safe, effective, and of high quality.

As Brexit rapidly approaches, the lack of clarity around the regulatory balance between the regions could lead to a reduction in standards.

This coming year could see a combination of regulatory uncertainty and inactivity for the pharma industry, mainly as a result of Brexit.

FDA sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.

Sanofi has been granted marketing authorization by the European Commission for its dengue vaccine, Dengvaxia, following the earlier recommendation of approval by the EMA's CHMP

Despite ongoing efforts to address drug shortages, FDA now sees a rise in active shortages and in the duration of supply problems.

The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.

The UK Pharma Industry has emphasised the need for the government to avoid a 'no-deal' Brexit in response to the prime minister delaying the deal vote.

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

New FDA guidance developed to identify lapses in data integrity and promote best practices.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

The EMA has published a revision to its guideline on the environmental risk assessment of human medicines.

NICE has recommended the use of regorafenib as a treatment for NHS patients with advanced liver cancer, following consideration of a new commercial arrangement.

Novartis has announced that the European Commission has approved Gilenya (fingolimod) as a treatment for children and adolescents (10–17 years) with relapsing-remitting forms of multiple sclerosis (RRMS).

Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.

The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.

A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.

Microbial identity data can be critical for determining contamination sources.