China Lifesciences Monthly Update - February/March 2017

China

NHFPC issued the Administrative Measures for the Registration of Doctors Practising, 2 March

The National Health and Family Planning Commission (the “NHFPC”) issued the Administrative Measures for the Registration of Doctors Practising (the “Measures”) on 2 March 2017, which repeals the Interim Measures for the Registration of Doctors and will enter into force on 1 April 2017. The measures allow doctors to practise in several medical institutions. If doctors want to practice in more than one institution, the doctors shall identify one institution as their main practice institution, and apply for practice registration to the local HFPC authority that supervises this institution. For other institutions, doctors will need to apply a record filing to the local HFPC.

NHFPC revised the Implementing Rules for the Administrative Regulations on Medical Institutions, 28 February

The NHFPC released the Decision on Revising the Implementing Rules for the Administrative Regulations on Medical Institutions (the “Decision”) on 28 February 2017. The Decision will enter into force on 1 April 2017. The Decision expands the scope of medical institutions to include maternal and child health care family planning service centres, medical test laboratories, pathological diagnosis centres, medical imaging diagnostic centres, haemodialysis centres, peaceful treatment and nursing centres.

CFDA and six other authorities issued  the Guiding Opinion on Promoting the Development of Informative Traceability Systems for Key Products, 23 February

The China Food and Drug Administration (“CFDA”) and six other authorities issued the Guiding Opinion on Promoting the Development of Informative Traceability Systems for Key Products (the “Opinion”) on 23 February. The Opinion aims to establish traceability systems for edible agricultural products, food, drugs, agricultural production materials, special equipment, hazardous articles and rare earth products by 2020. For drugs traceability systems, the Opinion promotes the traceability systems of the circulation of traditional Chinese medical materials, and the rapid traceability systems of all drugs in the whole process from production and circulation to use.

MHROSS issued the National Reimbursement Drug List (2017 edition), 21 February

The Ministry of Human Resources and Social Security (“MHROSS”) issued the National Reimbursement Drug List (2017 edition) (the “List”) on 21 February 2017 to replace the edition issued in 2009. The List has four sections: general statements, western drugs (including chemical drugs and biologics), Chinese patent medicines and Chinese herbal slices. The social security authorities of every province (both autonomous regions and municipalities) are required to issue their local reimbursement drug lists before 31 July 2017.

State Council published 13th Five-Year Plan for National Drug Safety, 14 February

The State Council published the 13th Five-Year Plan for National Drug Safety (the “Plan”) on 14 February 2017. The Plan outlines the following action points: accelerating the evaluation of the quality and efficacy of generic drugs, reforming the evaluation and approval system of drugs and medical devices, improving the national standard for drugs, medical devices and cosmetics, strengthening the whole process of supervision and strengthening the construction of the monitoring and evaluation system.