Regulatory Oversight

EMA Issues Concept Paper for Public Consultation on Development of Toxicological Guidance for use in Risk Identification.

Careful mixing during a product's distillation can help avert trouble from a strong concoction.

Russia is aiming to provide an alternative to China and India for drug manufacturing, including APIs.

June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.

In an age dominated by the internet and uncertainty over the best packaging security methods to employ, counterfeit medicines have the ideal environment to thrive.

Last week, FDA published a final guidance for pharmaceutical manufacturers that plan to incorporate physical–chemical identifiers in solid oral dosage forms as an anticounterfeiting strategy.

Letting contamination build up can cause multiple headaches.

In an effort to balance bilateral trade, India is urging China to increase Indian pharmaceutical imports.

FDA has published a guidance on Marketed Unapproved Drugs-Compliance Policy Guide, which describes the agency's enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter drug review.

FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA's policies for issuing waivers, refunds or reductions in prescription drug user fees.

USP Expands Presence in India.

Being aware of a forthcoming inspection or how a product was made can make a huge difference.

Growth and change in Brazil and Mexico offer key opportunities for the region's pharmaceutical industry.

The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.

USP and the Brazilian National Agency of Sanitary Surveillance are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil.

FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets.

EMA announced that a new version of the validation criteria for electronic applications for human medicines comes into effect on Sept. 1, 2011.

Since China's State Food and Drug Administration revised its GMPs last year, the agency has been making other improvements as well to improve the quality of its pharmaceutical manufacturing industry.

FDA Issues Final Guidance Regarding cGMPs for PET Drugs.

Contract manufacturing organizations throughout Asia are increasing their capabilities to meet market demand and attract foreign investment and partnerships.

Visiting a new site or going down memory lane may not get you where you want to go.

A public consultation has opened in Europe for the revised guideline on the good distribution practice of medicinal products for human use.

FDA issued a draft guidance for industry comment on proposed policy for diagnostic tests used with targeted drug therapies, that is personalized medicine.

FDA issued a draft guidance, entitled "Q11 Development and Manufacture of Drug Substances," which is now available for comment according to a notice published on June 29, 2011, in the Federal Register.

The European Medicines Agency has responded positively to a new directive published in the Official Journal of the European Union addressing concerns over increases in falsified medicines in the supply chain.

Getting an answer is easy-asking the right question is apparently more difficult.

Member states in the EU are working to implement the newly passed Falsified Medicines Directive.

FDA Publishes Final Guidance on Dissolution Testing.

The European Medicines Agency (EMA) has held a second forum regarding the implementation of new pharmacovigilance legislation, which gave stakeholders the opportunity to discuss their expectations on various aspects of the new legislation's execution.

The Association of the British Pharmaceutical Industry (ABPI) has published a guidance that suggests best practices for managing adverse events and other pharmacovigilance data from the internet and social media tools.