Report on the Drug Registration Process in China

Report on the Drug Registration Process in China

China's pharmaceutical drug market is constantly growing and is the second-largest pharmaceutical industry in the world, after the United States. It is estimated to reach $161.8 billion by 2023, with an average growth rate of 5% in the coming years, taking a 30% share of the global market.

Highlights of China’s new provisions and opportunities for drug registration

Let's look at some highlights of new provisions made by the Chinese regulators

  • The 60 days of timeframe for CTA approval following the global regulations.
  • Clear timelines for review and approval for different types of drug registration applications.
  • Streamline processes between drug registration and manufacturing authorization to ensure GMP.
  • Improvement of communications between the applicant and Center for Drug Evaluation (CDE) for effective CTA process.
  • The introduction of parallel risk-based site inspections and lab tests registration conduction with the technical review.
  • Breakthrough and the conditional approval during the clinical trial stage, and the priority review during marketing approval expediting drug registration and satisfying unmet medical needs in China.

To register your drug in China, you need to know the following details

  • What are the different categories of drug products in China?
  • Which category does a specific product belong to?
  • What are the documents required to register the specific category of drugs?
  • What is the applicable accreditation or certification required for drug registration in China?
  • How about clinical trial data requirements and clinical study waivers in certain circumstances?
  • Who can register the medical products in China and/or hold the marketing authorization for a specific drug in China?
  • What is the overall process applicable for registering specific drugs in China?

Get Details on Regulatory, Requirements, and Process for Registering Drugs in China.

Credevo has prepared this report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.

Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for registering pharmaceuticals in China. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared based on relevant information from the public domain as of the date, however, the Chinese regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of registration.