Ropes & Gray LLP (JD Supra China)

After almost two years of extensive review and deliberation, the Chinese legislature finally passed the new Drug Administration Law (“DAL”) on August 26, 2019, which will go into effect on December 1, 2019.

After continuously reshaping the competitive landscape in the pharmaceutical industry for several years, the Chinese government finally shifted its attention to the medtech industry. The central government released several reform initiatives that may fundamentally affect business models and commercialization strategies for medical device companies in China. Amongst them, two of the most...

China’s State Council, the country’s top administrative authority, released a new Regulation of Human Genetic Resources1 (the “Regulation”) on May 28, 2019, to replace the tentative rules issued in 1998. The Regulation, which will take effect on July 1, 2019, illustrates the Chinese government’s clear intent to position the regulation of HGRs as one of its national security priorities....

On April 20, 2019, the Chinese government submitted a second draft of the Drug Administration Law of the People's Republic of China (Second Draft for Deliberation) (“DAL”) to the Standing Committee of the National People’s Congress of China (the “NPC”) for deliberation. The government intends to introduce structural changes to the DAL in order to incentivize innovation and reinforce post-approval

China’s drug and device regulator recently announced a set of rules signaling increased scrutiny of foreign drug and device companies. On December 26, 2018, the National Medical Products Administration (the “NMPA”) released the Regulations for Drug and Device Overseas Inspection (the “Regulations”). The Regulations set out a working procedure for the NMPA to verify whether foreign drug and device

On September 14, 2018, the PRC National Health Commission (“NHC”) promulgated three administrative measures1 (the “Measures”) to regulate telemedicine. The Measures recognize the legitimacy of emerging internet-based healthcare services, in addition to traditional telemedicine services defined by the existing regulations. By way of background, the NHC defined telemedicine narrowly in its 2014...

On March 17, 2018, the Chinese State Council passed the Scientific Data Administrative Measures (the “Measures”) to standardize the management of scientific data at a national level. The Measures, which took effect immediately upon issuance, impose a number of requirements on research institutions, higher education institutions, and enterprises (collectively, “Research Entities”), many of which...

The PRC Ministry of Justice recently published a comprehensive draft amendment (“Draft Amendment”) outlining the proposed revisions to the current Medical Device Regulations (MDR, previously known as the State Council Order # 650). The Draft Amendment is now ready for public comments until July 24, 2018.

In response to the central government’s calling for a data protection mechanism, the China Drug Administration (the “CDA”) published a draft on Implementing Measures for Pharmaceutical Study Data Protection (the “Draft”) on April 25, 2018 for public comments. This Draft specifies data protection scope, extends the data protection period, and, for the first time, proposes a working procedure for...

China’s Government will launch several incentives to enhance accessibility of innovative drugs, especially imported oncology drugs. The State Council, China’s cabinet, has decided not to apply any tariff on imported drugs, and will include imported new drugs (especially urgently required oncology drugs) in the government-funded Basic Medical Insurance on a rolling basis. Companies can use their...

On March 17, China’s highest legislative body, the National People’s Congress, approved a sweeping government restructuring plan. This is generally considered to be the most comprehensive government restructuring that China has undertaken since the country implemented its “Open Door” policy in the late 1970s. As part of the new plan, China has established a State Market Regulatory Administration (

On January 10, 2018, the China Food and Drug Administration (“CFDA”) announced the implementation of the Technical Guidelines Governing Acceptance of Medical Device Clinical Data from Foreign Studies (the “2017 Guidelines”). The long-awaited 2017 Guidelines explain the principles, acceptance criteria, technical requirements and considerations for accepting foreign study data in support of...

The China Food and Drug Administration (“CFDA”) recently proposed two draft circulars for public comments, namely (a) the Technical Guidelines for Conditional Approvals for Urgently Needed Drugs (“Draft Conditional Approvals Guidelines”) and (b) the Administrative Measures for Compassionate Use of Investigational Drugs (“Draft Compassionate Use Measures”). The CFDA is soliciting public comments...

On November 4, 2017, the Standing Committee of the National People’s Congress (“NPC”) adopted amendments to China’s Anti-Unfair Competition Law (“Amended AUCL”). In 1993, the Chinese government enacted the AUCL to encourage and protect fair competition among businesses in a then-burgeoning Chinese economy. In the years since, the AUCL became the seminal governing authority for the State...

The China Food and Drug Administration (CFDA) has published its proposed amendment of the Medical Device Regulations (MDR), previously known as the State Council Order # 650, for public comments. This Alert summarizes the key changes.

The China Food and Drug Administration (CFDA) published its proposed amendment of the Drug Administration Law (DAL) and the Drug Registration Rules (DRR) for public comments. This Alert summarizes the key changes.

In August 2017, multiple departments of Shanghai government, led by Shanghai’s Health and Family Planning Commission (“Shanghai HFPC”), jointly issued a series of administrative rules (collectively, “Recent Shanghai Rules”) to tighten the interactions of pharmaceutical and medical device companies with health care professionals (“HCPs”) working in Shanghai hospitals and to crack down on...

Based on the CFDA’s policy proposals published in May 2017, China’s central government announced its final policy for drug and device regulatory reform on October 8, 2017 (“Final Policy”). The Final Policy reiterates the importance of creating an innovative-conducive regulatory system and incorporates the CFDA’s main proposals to deregulate the conduct of clinical studies, to accelerate drug and...

On August 31, 2017, the China Food and Drug Administration (“CFDA”) announced the final revision to the 2002 Medical Device Classification Catalogue (“2002 Catalogue”). The revised version (“New Catalogue”), which will become effective on August 1, 2018, updates the device classification significantly and will have considerable impact on device registration, manufacturing and distribution. Device

On June 1, 2017, China’s new cybersecurity law, the Network Security Law of the Peoples Republic China (“Cybersecurity Law”) went into effect. The Cybersecurity Law contains an overarching framework regulating network products, equipment, and services, as well as the operation and maintenance of information networks, the protection of personal information, and the supervision and administration...

Recent press reports in China have indicated that China’s National Development and Reform Commission (NDRC), one of China’s three antitrust regulators, is launching an inquiry into firms in the foreign finance sector to determine if they have engaged in price fixing. While the NDRC has not released any public information regarding the probe, local sources note that it is likely to be in its early

On May 19, 2017, China’s State Council promulgated the amendments to the 2014 Regulation on the Supervision and Administration of Medical Devices (“the Amendments”), which became effective immediately. The Amendments clarify issues related to device distributors’ liabilities of selling non-conforming products, the use of large medical equipment, and revocation of clinical study site certification.

On May 11-12, 2017, the China FDA (CFDA) issued four new draft policies for public comments, proposing further reforms in the current drug and medical device regulatory regime. The four draft policies aim to accelerate the review and approval of new drug and medical device applications (Circular No. 52), deregulate the conduct of clinical trials to encourage innovation (Circular No. 53), enhance...

China will launch further reforms in the pharmaceutical sector as part of the healthcare reform initiatives announced by the State Council in its February 9, 2017 Circular on Several Opinions Concerning Further Reforms of the Policies Governing Drug Production, Circulation and Usage (the “Circular No.13”). The Circular No. 13 sets forth general principles of the reform. Detailed implementation...

Recently China’s Food and Drug Administration (“CFDA”) released the Provisions for Medical Device Recall (“New Recall Rules”). The New Recall Rules, becoming effective on May 1, 2017, will replace the existing Interim Provisions for Medical Device Recall promulgated by the former Ministry of Health in 2011 (“Existing Recall Rules”). The New Recall Rules follow the basic regulatory framework for...

The China Food and Drug Administration (“CFDA”) recently proposed revisions to the Good Clinical Practices for Pharmaceuticals (“GCP”), the most comprehensive revision in 13 years. The revisions (“Revisions”) are now open to public comments until January 31, 2017.

While travel and entertainment expenses have presented significant compliance challenges for life sciences companies operating in China, donations and grants can also pose notable compliance risks. China’s escalated anti-corruption enforcement in recent years is well-publicized, and regulators have taken interest in grants and donations in the life sciences space.

China’s recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable. However, the legal consequences for breaching data integrity requirements in clinical trials remain ambiguous. On August 24, 2016, the China FDA (“CFDA”) issued a draft Guideline for Handling Issues Identified in Clinical Trial Data Inspections (“Draft Guideline”). The Draft Guideline...

Ask a senior manager of a MedTech company in China what keeps her or him awake at night and “regulatory changes” will invariably be among the first things mentioned. In fact, in McKinsey’s 2016 survey of MedTech CEOs, regulation tops the list of critical issues MedTech leaders face. Please see full Article below for more information.

The China Food and Drug Administration (“CFDA”) recently published long-awaited and comprehensive revisions (“Revisions”) to the Drug Registration Rules (“DRR”). The Revisions are now open to public comments until August 26, 2016. Since the DRR is the most important regulation for seeking approval of drugs in China, the pharmaceutical industry is advised to review the Revisions carefully and...