On May 9, 2022, The General Department of the National Medical Products Administration (NMPA) issued draft guidance on Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China.
New provisions and new contents of the new implementation regulations are first proposed, pointing to many focus issues, or consolidating the achievements of drug regulatory reform in recent years.
The Regulation Mainly describes the main important provisions of the draft guidance. Read below:
1. Encouraging innovation
• The State points out they would like to improve the drug innovation system, support basic research, applied research and original innovation of drugs, support clinical value-oriented drug innovation.
To do this they will strengthen the protection of drug intellectual property rights and improve the ability of independent drug innovation.
• Promote the modernization and internationalization of traditional Chinese medicine.
2. Accelerate Marketing Channel
It is proposed, again, that NMPA should establish breakthrough therapeutic drugs, conditional approval for marketing, priority review and approval and special approval systems, encourage drug development and innovation, and shorten the process of drug development and review.
Four procedural regulations are:
1.0 Criteria for Breakthrough Therapy (BT):
During local clinical trial:
- Innovative drug or modified new drug
- Prevent/treat serious life-threatening diseases or a disease that seriously impairs the quality of life and no effective prevention and treatment measure is available
- if sufficient evidence is available demonstrating that the drug has substantial clinical superiority over existing therapies
- Priority review
- Rolling submission
2.0 Criteria for Conditional Approval (CA)
During Iocal clinicaI trial, the clinicaI data can predict its efficacy and clinical benefits:
- For the target indications are serious and life-threatening diseases, and the existing treatment methods have unmet clinical needs
- Urgent need of drugs for the treatment of rare diseases
- Drugs urgently needed in public health
- Vaccines urgently needed in response to major public health emergencies or other vaccines recognized by the state health administrative department and listed in the special approval procedures
- Priority review
- PAC alignment before NDA approval
3.0 Priority review (PR)
- Breakthrough drugs
- Conditional approval drugs
- New drugs in shortage and the urgent need for major infectious diseases
- Drug for rare diseases
- New varieties for physiological characteristics of children
- Innovative vaccines for urgent need
- Others regulated in PR regulation
- NDA review timeline shortened
- Priority on inspection, QC testing, Generic name check
4.0 Special Approval (SA)
- Decided by NMPA to manage public crisis
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