국가임상시험지원재단

● Clinical Trial Regulation Implementation in Germany

Janet Koenig(BfArM) 

The new European Clinical Trials Regulation 536/2014 will replace the still valid European Directive 2001/20/EC. The legislation becomes a regulation, rather than a directive, which will ensure key aspects have identical rules throughout the EU. The new regulation aims to harmonise authorisation and reporting procedures for clinical trials and introduces of a joint European assessment for multinational clinical trials in the EU. Despite the joint assessment administered by a reporting member state, however, each member state will continue to authorise clinical trial applications nationally. The new procedures will also require close cooperation between the competent authorities and national ethics committees in the assessment of clinical trial applications. In Germany, a pilot project was started to simulate the future processes of the regulation in line with current legal requirements and in order to give applicants, competent authorities and ethics committees the opportunity to get familiar with the new procedures.
Compliance with the deadlines set by competent authorities and ethics committee shows that the technical infrastructures and processes established in the pilot procedure are fully functional. From the perspective of the parties involved, the cooperation between competent authorities and ethics committees was seen to be very successful.  

● Regulatory Reform to Support Clinical Development of Innovative Products in China

Ling Su(China)

Since June 2015, China has implemented an unprecedented comprehensive reform of its regulatory system. In June 2017, the Chinese regulatory agency became a regulatory member of ICH. All of these have brought about significant changes to many aspects of new drug development, approval and regulation in China and have important impact on all stakeholders including the industry, research organizations and the regulatory agency. In this brief presentation, the following topics will be discussed:
- Acceptance of overseas clinical data to support drug registration in China, particularly in the context of multi-regional clinical trial (MRCT) and ICH E17
- Acceptance of overseas clinical data to support drug registration in China, particularly in the context of multi-regional clinical trial (MRCT) and ICH E17?

● Preparedness and Execution of Chinese Regulatory Reform

Chang Lee(PAREXEL)

China is the 2nd largest pharmaceutical market worldwide, and an attractive country for biopharmaceutical companies to conduct clinical research.  The major drivers of the growth include the unmet medical needs, the expanding middle class, stronger belief in innovation economics, greater in-flows of investment, and the central government’s policies. As of September 1, 2018, the Chinese FDA “CFDA” English abbreviation has officially been changed to NMPA - National Medical Products Administration. NMPA approval timelines have been dramatically reduced: there were 324 new drug applications in 2017; CTA approval was 110 days in 2017, and it is 57 days in 2018. The NMPD/CDE reviewers grown from 120 to 800 in a short time.  Foreign data can be accepted for registration if there is no ethnic difference in the patient population; In July 2018, a list of 48 drug products approved outside of China but not yet in China was published by NMPA for priority review. Those 48 products can be approved in 3-6 months based upon overseas data. Innovative drugs can now be listed in the National Reimbursement Drug List (NRDL) through price negotiation with the government.  China approves 17 anti-cancer drugs for medical insurance coverage on October 10, 2018.  This talk will present relevant regulatory, clinical & product launch strategies, four clinical innovations that have promise in decreased patient recruitment timelines, increased likelihood of launch, and inclusion on payer formularies, and multichannel communications with NMPA/CDE to obtain development agreements.

1. Janet Koenig(BfArM)

2. Ling Su(China)

3. Chang Lee(PAREXEL) 

 상기 과정은 보수과정으로 직능별, 단계별 인정가능시간이 상이함으로 관련규정 '[별표1] 임상시험등 종사자별 교육과정 및 이수시간'을 꼭 확인하시기 바랍니다.

[별표 1]

임상시험등 종사자별 교육과정 및 이수시간

(제5조 관련)