Regulatory Beat - BioPharm International

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Regulatory Beat

Extending the Scope of Pharmacovigilance Comes at a Price

September 1, 2014

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Data Integrity Key to GMP Compliance

September 1, 2014

FDA demands accurate manufacturing and test information to ensure product quality.

Changes and Challenges for Generic Drugs

August 1, 2014

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

Industry Seeks Clearer Standards for Track and Trace

July 1, 2014

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

EU Steps Up Inspection Efforts

May 2, 2014

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.

Demand for New Vaccines Spurs Innovation

May 1, 2014

New formulations and expanded vaccine production are encouraged.

Quality by Design Bridging the Gap between Concept and Implementation

April 1, 2014

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

FDA and Manufacturers Seek a More Secure Drug Supply Chain

April 1, 2014

New identifiers and tracking requirements aim to block illegitimate products.

European Union Packaging Safety Features Come into Effect

March 1, 2014

Manufacturers are taking measures to comply with new package safety rules.

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