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Sep 4, 2016

Chinese Manufacturers struggle with Quality
While Chinese companies export about 50% of global APIs they struggle with international quality requirements

Chinese companies now account for more than 50% of the global active pharmaceutical ingredient (API) market. It has more than 500 companies registered to sell in the U.S. and 10 times that many serving its own market. But many of those continue to struggle to meet international standards.

As an example, Bloomberg points to the fact that last year, Chinese authorities ordered about 700 Chinese firms to review pending drug applications and withdraw any that were false or incomplete in an effort to step up its drug quality oversight. About three-quarters of the applications were voluntarily withdrawn or rejected by China’s regulators, even though some of the drugs also were approved for sale in the U.S.

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CFDA sets out punishments for counterfeit clinical trial data
Chinese authorities try to go against this trend by enforcing new legislations of punishment and fines

The China Food and Drug Administration (CFDA) has released a notification setting out "Punishments in Relation to Problematic Clinical Trial Data During Inspections”. The notice is described as following in the wake of the State Council-ordered reforms to the drug and medical device review and approval system, and the self-audit campaign initiated by the CFDA from July 2015. The latest notice is open for public feedback on punishments.

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Better monitoring of biological medicines
New chapter in guidelines on good pharmacovigilance practices

The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), entitled “Product- or population-specific considerations II: Biological medicinal products”. Good pharmacovigilance practices are a set of measures designed to ensure the robustness of the system of safety monitoring. The new chapter provides guidance on how to better monitor and manage the safety of biological medicines to optimise the safe and effective use of these products in Europe.

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Data integrity: key to public health protection
New guidance now available on EMA’s website

The European Medicines Agency (EMA) has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and efficacy of medicines and to monitor their benefit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities.

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EU collaboration strengthens safety monitoring of medicines
European Commission publishes three-year report on implementation of pharmacovigilance legislation

Closer collaboration between the European Medicines Agency (EMA), the European Commission and the EU Member States, enabled by the new European pharmacovigilance legislation, has enhanced the monitoring of the safety of human medicines throughout their life cycle, for the benefit of patients. This is highlighted in the European Commission report on the pharmacovigilance activities of the European medicines regulatory network published today.

The report describes the activities of the EU system for monitoring and managing the safety of human medicines from the time the new pharmacovigilance legislation came into effect in July 2012, until July 2015.

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Transparency in drug regulation
Publication of assessment reports in Europe and Australia makes information on medicines more easily available

In a joint article published by Drug Discovery Today, the European Medicines Agency (EMA) and the Therapeutic Goods Administration (TGA) in Australia describe their positive experiences with the publication of assessment reports for medicines – known as European public assessment reports (EPARs) in Europe and Australian Public Assessment Reports (AusPARs) in Australia. According to the authors, increasing web traffic highlights the regulators’ success in facilitating access to medicines’ information and the rationale for medicines’ approval.

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