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‘Customized strategies needed for fast-changing Chinese drug regulation’
  • By Jeong Sae-im
  • Published 2019.06.21 14:12
  • Updated 2019.06.21 14:12
  • comments 0

Foreign drugmakers need to make the most of China’s revised drug regulations to tap the Chinese pharmaceutical market, experts said at a recent forum in Seoul. China is going through sea changes in regulations on clinical trials and drug approval.

Korea National Enterprise for Clinical Trials (KoNECT) and the Korea Drug Development Fund (KDDF) held a forum on global clinical development to discuss China’s deregulation and strategies for clinical development at the KoNECT’s head office in Seoul, Thursday.

Jessica Liu, head of international business at TigerMed, speaks at a forum on global clinical development in Seoul, Thursday.

Speakers, including Jessica Liu, head of international business at TigerMed, a Chinese contract research organization (CRO), and CUREnCare Research CEO Moon Han-lim, shared their expertise at the forum.

China is one of the largest markets in the world, but international pharmaceuticals found it tough to penetrate the market due to onerous regulations.

However, there has been a massive change in the way the Chinese government views the pharmaceutical industry recently. Now, Beijing is taking strong reform measures to nurture the sector as a major growth engine.

Liu said China's clinical development system has undergone significant reforms since 2017 and summarized them with six points.

The six reforms are as follows: It is possible to submit new drug application (NDA) directly with data of multiregional clinical trial (MRCT) completed in China; China accepts overseas clinical data; it is possible to conduct phase-1 clinical trials in China simultaneously, and phase-2 data outside of China is unnecessary for MRCT application in China; no certificate of a pharmaceutical product (CPP) is required in the clinical trial application (CTA) and NDA in China; priority approval is given to innovative drug for rare and incurable diseases (conditional approval, review time shortened through priority review); and the government introduces a new review/approval system (reducing the screening period for clinical trials to 60 working days).

She said several drugmakers won the nod through updated procedures.

“There was a case that received approval through MRCT, or another case in which phase 1 and 3 were concurrently carried out in China for drugs that were manufactured overseas and completed phase 1 and 2 tests,” she said.

Companies need to set different strategies according to their situations, she added.

According to Liu, seeking NDA through MRCT is beneficial, but it has limitations in recruiting Chinese patients, and there is no early-stage Chinese study to reference.

If a foreign firm wants to release an innovative drug for a rare and intractable disease that already sells in other countries, it can receive conditional approval through fast-track review without a local trial and submit safety and efficacy data in post-marketing surveillance.

CEO Moon introduced an example where excellent global trial data led to conditional approval in China.

“One company that earned good results in a global study heard from the Chinese authorities at a pre-NDA meeting that it could obtain quick approval without a trial in China and conduct the study after the market release,” Moon said.

Drug companies can also make the best of the shortened duration of clinical trial approval from 110 business days to 60 business days, he said.

“Chinses hospitals used to shun an institutional review board (IRB) before seeking investigational new drug (IND) approval. As the review period was reduced, however, more hospitals are willing to attract clinical trials,” Moon said. “It is a good strategy to apply for IRB and IND simultaneously, or apply for IRB before approval.”

Liu emphasized that pharmaceuticals need to closely communicate with the Chinese authorities in a pre-NDA meeting to set up a good strategy.

“As much as the trial and new drug review got shortened, there are things that drugmakers must prove. To discuss those matters, communication with the authorities is crucial,” she said.

If you have a plan to enter China, you’d better start the communication as soon as possible, Liu added.


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