Quality Systems

Articles

The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.

Companies Stepping Up Efforts to Ensure Medicine Supply Post-Brexit

Agnes Shanley is senior editor of Pharmaceutical Technology.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

After Valsartan Recalls, Regulators Grapple with Nitrosamine Contamination in APIs

The agreement now includes 15 European Union (EU) member states.

Portugal to Benefit from EU-US Mutual Recognition Agreement for Inspections

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.

FDA Clarifies Worldwide Inspection Policies

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

The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars. 

Disputes Over SPC Waivers

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.

Checking Incoming Goods

Andrew Teasdale, PhD, is a Principle Scientist at AstraZeneca.

Nancy Lewen is research fellow, CSD Analytical chemistry, Bristol-Myers Squibb.

Elisabeth Corbett is associate director, Global Regulatory Sciences, CMC, Bristol-Myers Squibb.

Lina Wong is associate director, Global Quality Assurance, Allergan.

Shoreh Shabrang is senior consultant RA CMC, SAABAS LLC.

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.

Pharma Collaboration Proposes Retirement of Obsolete Heavy Metals Tests

The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.

EC Approves GSK’s Nucala for Pediatric Treatment of Severe Asthma

The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

EC Approves Novartis’ Kymriah CAR-T Cell Therapy

Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.

Regulatory/GMP Compliance, Europe