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Asia Regulatory Roundup: China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal

Posted 05 March 2019 | By Nick Paul Taylor 

Asia Regulatory Roundup: China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal
 
China is planning to introduce a risk-based regulatory system for cell and gene therapies in the wake of the germline modification scandal. The system would require developers of high-risk therapies to get state-level clearance for clinical trials, while leaving local authorities to sign off on less-dangerous technologies.
 
The Chinese regulation of advanced medical technologies has been in the spotlight since a scientist claimed to have engineered the genes of human embryos to render them resistant to HIV. If true, the research would make this the first time the human germline has been genetically engineered.
 
Chinese authorities argue the germline work was prohibited under 2003 in-vitro fertilization rules but have nonetheless reviewed oversight of the field. The result is draft regulations and an accompanying explainer that set out how China plans to facilitate clinical research while preventing lapses in ethics, privacy, safety and other areas.
 
The plan is to divide up oversight by risk, thereby ensuring tougher scrutiny of programs that pose the biggest threat. Examples of high-risk programs that will be subject to state-level oversight include projects involving cells, tissues, organs, changes to genetic materials and synthetic biology. Other technically challenging projects with potentially significant impacts could be classed as high risk, too.
 
China is also planning to restrict research on advanced biomedical technologies to institutions that meet certain criteria. These sites will need to put a qualified person in charge of clinical development programs and task them with handling problems quickly. Separately, sites must give someone overall responsibility for clinical development, improving quality and related tasks.
 
In the case of the gene editing scandal, the university and hospital affiliated with the researcher denied knowledge of the work. The draft rules appear designed to force institutions to know more about the research their staff perform in the future.
 
Organizations and individuals that fail to comply with the draft rules face punishment. Penalties sanctioned under the proposals include lifetime research bans, the revocation of business licenses and prosecution in criminal courts.  
 
China is accepting feedback on the draft until 27 March.
 
Draft Rules (Chinese), Bloomberg
 
Philippines Finds Cause for Criminal Case Against Sanofi Over Dengue Vaccine
 
A panel created by the Philippine Department of Justice (DOJ) has found probable cause for indicting Sanofi officials over their involvement with the dengue vaccine Dengvaxia. The finding could lead to six officials being charged with reckless imprudence and facing years in prison.
 
The Philippines was a big early buyer and backer of the dengue vaccine, but its relationship with Sanofi soured as safety concerns emerged in 2017. To assess what happened, the DOJ created a panel and tasked it with looking into tens of people involved with the vaccine, including a handful who work at Sanofi. The panel found Sanofi and its staff contributed to a situation that officials in the Philippines claim led to the deaths of 10 children.
 
“The panel ... faulted Sanofi for failing to actively monitor and conduct close surveillance of Dengvaxia recipients. It also found that Sanofi did not extend any medical assistance to the victims or their families even after reports of serious adverse reactions surfaced,” DOJ wrote in its summary of the panel’s findings.
 
That conclusion could have serious consequences for Sanofi and the employees involved. The charge of reckless imprudence resulting in homicide carries a maximum prison sentence of six years per count. Sanofi plans to defend its employees against the accusations.
 
“We strongly disagree with the findings made against Sanofi and some of its employees and we will vigorously defend them,” Sanofi said in a statement shared with Reuters and other publications.
 
The criminal case could affect Philippine officials, too. In its report, the DOJ panel questioned why the vaccine was approved, purchased and in use in an immunization program while clinical development in Asia was ongoing. Former Department of Health Secretary Janette Garin and officials at the Food and Drug Administration (FDA) could be charged over their roles in the affair.
 
News of the DOJ panel findings comes shortly after the Philippine FDA revoked the registration for Dengvaxia in response to Sanofi’s alleged “brazen defiance” of the rules. Sanofi is contesting the FDA action.
 
DOJ Notice, Reuters
 
India Gives Manufacturers of Rational FDCs 4 Months to Seek DCGI Clearance
 
The Drug Controller General of India (DCGI) has given manufacturers of 83 fixed-dose combinations (FDCs) four months to seek nationwide licenses. The FDCs came to market via the state-level back door used by many irrational FDCs, but were deemed to be rational by Indian authorities.
 
As India wants to permit the continued use of the FDCs but has issues with the path they took to market, DCGI Eswara Reddy has asked manufacturers to seek clearance at the national level. The request applies to all manufacturers of the 83 FDCs that only hold licenses from state authorities, not no-objection certificates from DCGI.
 
To get DCGI clearance, the manufacturers must submit applications that include their state license, manufacturing license, data from stability studies and test specifications, plus INR 15,000 ($212) per FDC.
 
If a company fails to submit the requested information within four months, DCGI will not consider their applications and will cease to see their licenses as legally valid. Reddy told regional regulators in India to tell manufacturers about the requirements and enforce the sanctions against companies that fail to comply with the request.    
 
In a related development, Reddy published a notice stating that an FDC combining atenolol, losartan and hydrochlorothiazide is inappropriate. Manufacturers affected by the ruling can present scientific justification for the combination for consideration by Indian regulators. 
 
DCGI Notice, More
 
India Plans Tighter Rules on Brand Names to Prevent Confusion and Deception
 
India is planning to increase oversight of brand names. The draft proposal would require companies to assess whether similar brand names are already in use and share the findings with Indian licensing authorities.
 
In the United States, the Food and Drug Administration reviews brand names prior to approval and rejects one-fifth to one-third of original proposals, depending on the department involved. The review process is designed to prevent medical errors by stopping drugs with names that look or sound like those of existing products from coming to market.
 
The legislation put forward in India puts the onus for looking for products with similar names to the proposed brand on applicants, not regulators. If the system works as hoped, it will prevent confusion that can lead to medical errors and attempts to deceive patients and healthcare professionals.
 
Gazette Notification
 
Other News:
 
China’s National Medical Products Administration (NMPA) has released guidelines on the clinical development of three types of cardiovascular device, including transcatheter artificial aortic valves. NMPA thinks the guidelines will improve the quality of clinical trial programs and regulatory filings for the products. NMPA Notice (Chinese)
 
China’s Center for Drug Evaluation (CDE) has released advice on clinical development of biosimilar copies of AbbVie’s Humira. The loss of patent protection on the blockbuster inflammatory disease drug has spurred research around the world, with Amgen, Novartis and a clutch of Chinese biotechs among the companies trying to seize the opportunity. CDE Guidance (Chinese)
 
The Therapeutic Goods Administration (TGA) has found insulin products sold in Australia meet quality standards. TGA tested products from pharmacies and suppliers. TGA Notice
 

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