Regulatory Oversight

The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?

Pharma eyes biologics production in Brazil as the government begins to recognize the potential of these drugs.

FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.

Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.

The last few weeks have seen the media swamped with stories about the rampant bribery clawing the pharmaceutical industry in China.

Agencies collaborate to ensure consistent product quality.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

The guidance describes a risk-based approach to monitoring of clinical trials.

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

Industry players brace themselves to face challenges as India's new drug-pricing policy kicks in full gear.

The bio-pharmaceutical business outlook in South Korea remains positive.

Brazil offers opportunities and challenges for global pharmaceutical companies.

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.

The Alliance for Fair Trade with India is seeking action to resolve discriminatory trade practices and improved protection of intellectual property rights.

ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.

EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

A unique demographic and payer mix make ASEAN an increasingly attractive region.

The Taiwanese government engages in regulatory science in a move to boost its pharmaceutical sector.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies.

EMA streamlines orphan drug application procedure.

Prior to price escalation of pharmaceutical products in Brazil, the country's regulatory authority released a study on price-cap control and its benefits in the past years.

The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.

FDA issues draft guidance to minimize medication errors.

FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.