Analysis of innovative drug category 1.2 in traditional Chinese medicine and considerations on quality control of extracts / 中国中药杂志

In this article, the essence of innovative drug category 1.2 extracts and preparations in the new version of the New Drug Registration Category of traditional Chinese medicines(TCM) was analyzed by combing through the history of provisions on drug registration and comparing with other categories of drugs. After analyzing the characteristics of this type of preparations, the author concluded that the quality control objectives of category 1.2 extract should focus on ensuring the quality consistency of the active ingredients/components in batches, so as to guarantee the consistency of drug quality and efficacy. With reference to the relevant technical requirements for herbal medicinal products in European Medicines Agency(EMA) and botanicals in Food and Drug Administration(FDA),the key points in quality control of the extract should include the content and composition of the therapeutic constituents, the type and content of the concomitants, and the influence of exogenous contaminants on drug safety.

Empirical Analysis on the Policies of Drug Accelerated Assessment in the European Union / 中国药房

OBJECTIVE： To provide reference for in-depth reform of new drug assessment and approval system in China. METHODS： The legal basis of drug accelerated assessment policies in European Union （EU） were analyzed systematically， and then compared with other similar policies. The key steps of accelerated assessment procedure were introduced， in particular， pre-submission preparation， pre-licensing inspection， submission and evaluation of accelerated assessment application. Taking Maviret as an example， the effects of EU’s accelerated assessment policies were analyzed empirically. RESULTS： Accelerated assessment is one of the EU’s several legal provisions to foster patients’ early access to new drugs， as well as accelerated assessment and conditional market licensing， sympathetic drug use， priority drug program， orphan drug identification and hospital exemption， which were the main ways to obtain new drugs as soon as possible in the EU. The accelerated assessment was expected when the drugs had sufficient treatment data， significant public health benefits and innovation. Based on EU’s regulations （No. 726/2004/EC）， European Medicines Agency （EMA） had continuously improved the policy system of accelerated assessment， issued relevant guiding principle （guidelines） and timetables for the implementation of accelerated assessment procedures， providing detailed and specific guidance for the practical landing of the policy. Once the drug entered the accelerated assessment procedure， the assessment time would be shortened from 210 days of the standard procedure to 150 days. The assessment of Maviret， a new drug for the treatment of hepatitis C virus infection， was accelerated from Jan. 20， 2017 until Jun. 22， 2017. When it was approved by the EMA Committee for Human Medicinal Products （CHMP）， the whole process was less than half a year. CONCLUSIONS： EU drug acceleration assessment has not only perfect legislative support， but also detailed and specific implementation rules and timetable. It can speed up the marketing of drugs which are required urgently by the public and have speeific medical advantages.

Review of biosimilar regulatory guidelines and scientific principles:Experiences from Europe-an Medicines Agency (EMA) guidelines / 中国卫生政策研究

In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development ( R&D) procedures. The regulatory frame-work of the European Medicines Agency ( EMA ) guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respec-tively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R&D of biosimilars in the biopharmaceutical industry.