Regulatory Oversight

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”

The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.

The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

The Committee for Medicinal Products for Human Use recommended seven new medicines at a December 2014 meeting, including weight management and Parkinson’s disease treatments.

The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.

ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.

Generic drug manufacturing is no longer the only driver for growth in India's pharmaceutical market as more companies start investing in R&D.

Enhanced R&D efforts and the growing manufacture of finished-dosage drugs in India will shape the country's future success, according to a new report from CPhI.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Indian manufacturers are moving towards high-value, low-volume work, with complex chemistry and intellectual property challenges.

The authors explore and define common industry approaches and practices when applying GMPs in early development.

Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.

The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.

Margaret Hamburg, FDA Commissioner, visited China recently to oversee efforts to strengthen inspection and regulatory reviews and to attend the Ninth International Summit of Heads of Medicines Regulatory Agencies Meeting

Revised EMA policy reflects more balanced approach and experts are to submit updated declarations of interests by end of January 2015.

The European Medicines Agency responds to the European Ombudsman?s letter regarding redacted documents.

An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.

The authors explore and define common industry approaches and practices when applying GMPs in early development.

The Brazilian economy is being impacted by internal and external factors, and forecast figures are being quickly revised downwards.

Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

The European Medicines Agency releases highlights from its Pharmacovigilance Risk Assessment Committee safety review meeting in October.

FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.