Source From RDPAC?

CFDA Releases 4 Important Draft Regulations for Public Comment-Rare 'N Roll

On 11 May 2017, CFDA released a set of three draft regulation for comment to:

  • Encourage Drug/Medical Device Innovation and Accelerate Review/Approval (Document No. 52)
  • ?Encourage Drug/Medical Device Innovative Reform of Clinical Trials Management (Document No. 53)
  • Encourage Drugs/Medical Device Innovative Implementation of drugs/medical devices’ lifecycle management. (Document No. 54)
  • Protect drug and medical devices innovators’ rights and interests (Document No. 55)

Comments should be submitted by email before 25 May 2017. The main points of the three draft regulations are as follows:

Encourage Drug/Medical Device Innovation and Accelerate Review/Approval (Document No. 52)

  1. Accelerate High Clinical Unmet Need Drugs/Medical Device Review. Give conditional approval to:

Drugs/medical devices treating life threatening diseases that do not have efficient therapeutic treatment

Unmet clinical need drugs/medical devices, if early clinical phase or interim endpoints show efficacy and predictable clinical benefit.


  1. Support Development of Rare Disease Drugs and Medical Devices. NHFPC will issue a rare diseases’ list, and establish a patients’ record system.? Rare disease drugs and medical devices are eligible to apply for clinical trial waiver (CTW), and accelerated review. Conditional approval will be allowed and post-commitment studies will be conducted on time after approval for rare disease drugs and medical devices that have already received international approval.


  1. Strictly Manage Injection Formulation Review and Approval. The injection formulation will not need approval if oral formulation can meet clinical needs.


  1. Adjust drug substance, excipients and package materials management model. Draft drug substance, excipients and package materials record management regulations, establish an information platform for drug substance, excipients and package materials record.


  1. Improve Drug and Medical Device Review System. Establish a review system supported by inspection and testing. Establish a communication mechanism between reviewers and applicants - meetings with CDE when pre-IND, end of phase II and end of phase III should take place.


  1. Support Clinical Use of Innovative Drugs. Encourage medical institutions to preferably procure new drugs with clear clinical efficacy and reasonable price. Further improve and regulate the NRDL dynamic adjustment mechanism. Local authorities are allowed to organize provincial centralized procurement based on their own disease prevention needs.


  1. Support traditional Chinese medicine inheritance and Innovation.


  1. Establish Priority Review System based on Patent compulsory license


Encourage Drug/Medical Device Innovative Reform of Clinical Trials Management (Document No. 53)

  1. Management of clinical trial sites qualification records. Remove the qualification review of clinical trial sites.
  1. Support investigators and clinical trial sites to conduct clinical trials. Allow MNCs and international scientific research institutions to conduct Phase I clinical trials in China.


  1. Improve Ethic Committee (EC) System. Establish regional EC according to needs.


  1. Improve EC review efficiency. For IMCT in China, if leading PI site’s EC is approved, the remaining sites’ EC review can be waived.


  1. Prioritize clinical trial review procedure. Establish and improve the communication between reviewers and applicants. A pre-IND (Ph I and III) communication meeting is needed before submission. CTA/IND is considered as approved if CDE has no comments or rejection within 60 working days; applicants can then conduct the clinical trials accordingly.


  1. Accept overseas clinical trial data for registration. Overseas clinical data can be used for registration after site inspection if they meet Chinese regulatory requirements. IMCT can apply for NDA approval directly. For 1st NDA submission, the applicants should provide evidence there is no racial difference.


  1. Support expanded clinical trials development. If ongoing clinical trials of drugs/medical devices treating life-threatening diseases that have no effective therapy show preliminary clinical benefits and meet EC requirements, they can be used with patients’ informed consent; relevant safety data can be used for registration.


Encourage Drugs/Medical Device Innovative Implementation of drugs/medical devices’ lifecycle management. (Document No. 54)

  1. Carry out MAH license holders’ legal liability. Based on MAH pilot experience and DAL revision, carry out widespread implementation of drugs and medical devices MAH in China.


  1. Improve Drugs/Medical Device Adverse Reaction/Adverse Events (AE) System. Based on the current AE reporting system, establish MAH holders’ AE reporting system.


  1. Implement Marketed Injection Drugs Re-evaluation System


  1. Improve Medical Device Re-evaluation System


  1. Seriously punish clinical trial data fraud. Clinical trial project contract signatories and investigators will be the primary responsible persons and, will take legal liability for clinical data.


  1. Regulate scientific promotion behavior. Medical Representatives (MRs) are responsible for new drug' scientific promotion, introducing new drug information to clinical physicians and gathering after use feedback. MRs are prohibited from selling medical products and secretly meeting with physicians without permission. Medical institution personnel are prohibited from providing individual physician' prescription number to MRs or members of the pharmaceutical industry (manufacturing or distributing companies). MRs scientific promotion activities within medical institutions should be conducted openly and registered with the assigned department of the concerned medical institution. Any behavior misleading the use or disguising the adverse effects of drugs by MRs shall be investigated and punished seriously. Marketing Authorization Holders (pharmaceutical manufacturing companies) should get their MRs’ name list endorsed on the appointed website to be publicly launched. Any operating activities in the name of MRs without endorsement shall be investigated and punished as illegal operation of drugs by relevant authorities.


  1. Strengthen review and inspection capability building. Carry out electronic submission and review; create archive of marketed drugs/medical devices.


  1. Reform drugs clinical trial samples QC testing system. Clinical trial samples’ QC testing can be done by applicants or assigned labs, QC testing report can be sent to CDE.


  1. Carry out the whole life cycle inspection liability from research and development to drugs use. Strengthen site inspection and casual inspection based on risk and review requirements.


  1. Establish professional inspection teams.


  1. Enhance international collaboration. Deepen drugs/medical devices policy/regulation and technical communication, participate in global guidance and criteria revision, carry out globalized sharing and mutual recognition of review, inspection, testing and results.

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Protect drug and medical devices innovators’ rights and interests (Document No. 55)


  1. Set up drug patent linkage system. Applicants need to inform patent owner within 20 days after filing application.?If patent owner believes there is an infringement to its patent rights, it should file with judicial system within 20 days after receiving notification. The drug review agency will then put the new application on hold up to 24 months.
  1. Improve drug clinical trial data protection system.? Six years for new innovative drugs.? New innovative drugs treating rare diseases or children diseases will enjoy 10 years. Improved new drug treating rare diseases will enjoy 3 years.? New bio innovative products for therapeutic use will enjoy data protection period for 10 years.
  1. Government officials have a confidentiality obligation with regards to technical secrets and clinical trial data of submitted applications.
  1. Establish drug categories for approved drugs.? All approved drugs will be listed onto the China Approved Drug List; with clear indications of the nature of the drug (innovative or improved drug) and if the drug passed GQCE.