News

NMPA has Formulated Confidentiality Measures in Regards to Review and Approval of Drugs and Medical Devices.

In order to protect the rights and interests of the manufacturer of pharmaceuticals and medical devices, NMPA (China Food and Drug Administration) issued a code of confidentiality for all employees involved in the registration process.According to the code, all employees involved in a registration process must sign a confidentiality agreement, whose compliance is strictly monitored. Should an employee be in violation of the agreement, he will be punished. Depending on the severity of the failure, the consequence is a disciplinary punishment which can range from a written warning or dismissal up to legal action against the employee.If the applicant of the registration can prove that the information disclosed by relevant staff or expert leads to losses, he has the right to file a lawsuit.If the NMPA pays a compensation according to the judgment of people's court, they will reclaim part or all of the compensation costs from the violating employee or expert.For further information please contact:Cisema GmbHTel.: +49 89 4161 7389 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

Simplifications of clinical studies for medical devices and pharmaceutical products in China.On 11.05.2017 NMPA (China Food and Drug Administration) issued two announcements – no. 2017-52 and -53 – handling the simplification of clinical studies in China. Medical devices and pharmaceutical products can thus be launched in China much easier.1. Policies about promoting market approval of new and innovative drugs and medical devices:This proposal refers particularly to innovative treatment methods for life-threatening diseases. If such a product turns out to be successful at an early stage of the clinical study, it can be put on the market with reservations even before the clinical study has been finished.2. Policies about administration of clinical trials on the innovation of medical devices and drugs:This is an initiative which allows all hospitals and medical institutions to carry out clinical studies in China, which, up to now, only specially accredited hospitals of the highest category, were allowed to do. In the future, a medical institute only has to register on the NMPA website, in order to be allowed to perform clinical studies.Furthermore, the draft allows clinical studies which were performed abroad to be used for product registration in China, as long as they comply with the “Requirements of the NMPA Drugs and Medical Device Registration”. The only exception are eight Class III high risk medical devices like implantable cardiac pacemakers, blood pump, infusion pump for medicines, stents, artificial organs and orthopedic components (see NMPA Notice 2014/14 ).On 17.05.2017 the draft of the third revised list for medical devices exempted from clinical studies was issued. It contains 22 class II and 6 class III products.These measures will give Chinese patients a faster access to innovative and improved treatments and reduce the launching costs.NMPA has used much effort in the past years to make the registration process more efficient and safe. The number of employees working for registration was increased by 450 in a period between mid-2015 and end of 2016, which means a fourfold increase.In April this year the Supreme People’s Court of the People’s Republic of China announced a new interpretation of the criminal code, according to which persons who forge clinical studies are facing severe punishment. If a drug, which was registered with forged clinical studies and caused injury to a patient’s health, the forger faces a 10 years’ imprisonment – if the patient dies, even a death sentence is possible. Even if the drug in question was not registered and did not cause any harm, the submission of falsified registration documents is punished with a 3 years prison sentence. Should any organizations entrusted with the performance of clinical studies be involved in any fraud, their accreditation will be cancelled.For further information on the above topics, please contact:Cisema GmbHTel.: +49 89 4161 7389 – 00info@cisema.dewww.cisema.com

China Food and Drug Administration (NMPA) report on registration of medical devices in China.NMPA recently published its Annual Report 2016 on medical device registration. The number of registrations in Class II, III and IVD has increased to 8.653, which is a plus of 14.9 % compared to the previous year. The retracement suffered in 2015 was due to the various regulatory changes dating back to 2014 as well as the increase of application fees in 2015, but the current figures have reached the 2014 level again.A large percentage of applications for the registration of medical devices and IVD comes from abroad. Class II had 3.095 applications from abroad, which is an increase of 2% compared to 2015 and in Class III there were 2.818 applications, an increase of even 15%.The P.R. China continues to promote the import of high-end and high-cost medical devices from abroad. The top five class II and III product groups of foreign origin to be registered in 2016 were:

1. Implanted material and artificial organs (509) – was on place 2 in 2015
2. Medical optical instruments, devices, and endoscopes (406)
3. Medical electronic instruments and devices (285)
4. Medical polymer material and products (249)
5. Devices and instruments for OR, IR, and Doctor’s consulting room (141) – superseded dental care equipment.

According to the NMPA report 2016, top of the list of registrations of foreign class II and III products (including IVD) were the USA followed by Germany, places 3, 4 and 5 were held by Japan, United Kingdom and Korea.Further information concerning this topic can be obtained from:Cisema GmbHTel.: +49 89 4161 7389–00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

Online Trade - Deliveries Classified as Products for Personal Use.As of 1^st January 2018 the Chinese customs authorities will treat all commodities traded through CBEC as articles for personal use. The reason is that commodities traded through CBEC are for private persons and usually have a low value and low quantities.Another five pilot cities for CBEC will be nominated: Besides Hangzhou, Tianjin, Shanghai, Chongqing, Zhengzhou, Guangzhou, Ningbo,Shenzhen, Fuzhou und Pingtan, there will now be added Chengdu, Dalian, Qingdao, Suzhou und Hefei.More details for the supervision will be published shortly. It can be assumed, however, that certain product groups which normally need registration or certification, can be traded and imported freely through CBEC. Among these commodities are:Ordinary cosmetics such as lotion, cream, facial mask, shampoo

• Nutritional supplements such as vitamin and mineral preparations
• CCC products such as coffee machines, vacuum cleaner
• Freely traded medical devices such as electronic sphygmomanometer

It has not been decided yet if the new regulation also applies to infant formula.Further information on this topic can be obtained from:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

Simplified Registration of Cosmetics.The registration procedure for conventional cosmetics at Shanghai FDA has been simplified.In February 2017 NMPA published two new regulations, i.e. NMPA Ann, . # 7, 2017 (Filing Management of First Import Non-special Use Cosmetics through Shanghai Pudong) and NMPA Ann. #10, 2017 (Procedures for Filing Management of First Import Non-special Use Cosmetics through Shanghai Pudong)Based on these regulations, which are preliminarily valid for a test period (01.03.2017 to 21.12.2018) a simplified filing process for conventional cosmetics is applicable.The new regulations are only valid for cosmetics imported through Shanghai Pudong New Area. The so-called China-Responsible is a new concept in cosmetics management aspect. The China-Responsible, who has to be registered in the Shanghai Pudong New Area, is not just a legal agent for filing, but also functions as importer and distributor.The advantage of this new procedure is that the filing for conventional cosmetics at SH FDA can be made in one day, whereas the official way through NMPA registration may take up to three months. On top, the certificate issued by SH FDA does not have to be renewed after four years.Further information on the above topic can be obtained from:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

NMPA – New Application Deadlines for Cosmetics. As of Sept.1^st, 2017 the deadlines for the application of certificate renewals or changes will be as follows:

• Renewal application must be submitted six months before expiry and not four months as before
• Certificate changes, completions or corrections must be applied for ten months before expiry now. Renewal and change applications can be submitted at the same time.
• The technical review by NMPA for a certificate renewal will take three months counting from the acceptance date of the application.

Further information on the above topic can be obtained from:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

Successful Project Launch of Chery Jaguar Land Rover (CJLR) – Congratulations from Cisema on this great success.The Jaguar Land Rover Group recently launched the X260L project – the first Jaguar entirely produced in China.In this connection Hangzhou Zhongce Rubber Co. Ltd. was honored for their excellent product quality and management skills which contributed greatly to the successful project launch. In the past 3 years, Hangzhou Zhongce Rubber Co. Ltd. went through a comprehensive supplier development program held by Cisema.We at Cisema are happy about this great achievement and will continue to assist with advice and support.

Recalls of Medical Device Regulation Updated .On September 2nd 2016 a new draft for handling recalls of medical devices has been released. The revision will replace the current regulation 82/2010 from the Chinese Ministry of Health dated 28.06.2010. It describes the key points leading to a recall.

1. If the medical device poses hazardous risks
2. If the medical device does not meet the regulation standards
3. If during manufacturing and/or distribution violations of the current medical device regulations occur
4. If any further adverse events ask for a recall

The draft also gives some guidelines for the management of recalls.

1. When the recall occurs outside of China the appropriate departments of the NMPA have to be informed
2. Within China:- Monitoring the safety of medical devices- Communication, reporting and close cooperation with the NMPA- Organization of the recall – assessment, if applicable relabelling, modification of the quality manual and/or software up-grades. Also of course repairs or replacement of the device and its disposal have to be taken care of.- Compensation- Penalties

When there is proof of the defectiveness of the device, and the NMPA-Legal-Agent fails to report to the NMPA, the NMPA may initiate the recall.Violation of the regulations can result in fines for the NMPA Legal Agent or even cost him his license.Recalls will be published in the NMPA database stating details of the product, its manufacturer and NMPA Legal Agent.For more information please contact us:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

Introducing QR code for the China Energy Label (CEL).Back in spring the Chinese authorities AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine of P.R. China) and NDRC (National Development and Reform Commission) drafted a change of the energy efficiency labeling. The intention is to make it easier for Chinese consumers to check on the energy efficiency of a product using online media.See below example:[caption id="attachment_1345" align="alignnone" width="182"] credit: 24.08.2016: https://www.cnca.gov.cn/xxgk/ggxx/2016/201608/W020160803588217825962.pdf[/caption]With immediate effect the labels have to be adjusted and get approval from the China Energy Label Center (CELC). Starting October 1^st 2016 the import of products to China carrying the old efficiency label will be problematic.What has also changed is that web shops have to include the QR-code in their product description. Distributors have to do incoming goods inspections, to check on the CELC-registration and ensure that only conformal goods are traded.For more information please contact:Cisema China Certification GmbHTel.: +49 89 4161 7389 - 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

After the successful completion of a project for a Swiss medical device company, we were entitled by the “Switzerland Global Enterprise” (Swiss Chamber of Commerce) to carry the title „Certified Expert“.

NMPA simplifies registration of dietary supplements. At the end of February 2016, NMPA[1] published the revised administrative regulation for the registration and registration of food supplements by way of Notice No. 22. It will enter into force on July 1, 2016 and is a further step towards implementing the new food safety law in China, which was passed by the NPC[2] in April last year.The new Directive distinguishes between vitamin and mineral supplements and other food supplements. A positive list of authorised ingredients will also be introduced; a first draft was published in February 2016. Simplified regulations will apply to products made from these ingredients in the future.NMPA registration for vitamin and mineral preparations whose ingredients are on the positive list is no longer required. They only have to be registered once at the NMPA counter before the first import and can then be imported indefinitely.All other dietary supplements whose ingredients are on the positive list must still be registered with the NMPA, but after that date there is no need for re-registration after five years. Food supplements can then be imported indefinitely after a one-time registration at the NMPA counter.For all other dietary supplements whose ingredients are not on the positive list, nothing changes. They must still be registered with the NMPA and re-registered every five years.MOF[3] prevents cross-border Internet trade in food supplementsOn 7 April 2016, the MOF revised its rules on cross-border Internet trading (CBEC - Commodities Traded through Cross-Border E-Commerce) by issuing No. 40. In this context, a positive list was adopted listing the products which may continue to be traded across borders via the Internet. The entire Healthfood area is explicitly excluded. The Chinese customs authorities and CIQ[4] are responsible for the enforcement of the new regulation.Further information on the topics mentioned can be obtained from:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.de[1]China Food and Drug Administration[2]National People's Congress[3]Ministry of Finance[4]China Inspection and Quarantine Office