Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India Posts Guide to Revised Rules on New Drugs and Clinical Trials
India’s Central Drugs Standard Control Organization (CDSCO) has posted a guide to its new drugs and clinical trials rules. The document addresses common questions about the new rules, such as when clinical trial sponsors can benefit from a fast track open to India-focused development programs.
The Indian government published the New Drugs and Clinical Trial Rules, 2019 last month. Through the document, India is making significant changes to the rules governing how drugs are developed in the country, generally in ways that have met the approval of the biopharma industry in the country and overseas.
To help companies understand the implications of the rules, CDSCO has shared answers to frequently asked questions about the regulations. The document covers everything from very broad and basic questions, such as, “What is an investigational new drug,” to more specific inquiries.
The more specific sections include an assessment of when CDSCO will fast track the processing of clinical trial applications. CDSCO aims to handle all clinical trial filings within 90 working days, but is offering a 30-day turnaround to certain innovative, Indian-focused development programs.
In the document, CDSCO states that a drug is eligible for the fast track if it “is discovered in India or research and development of the drug are being done in India and also the drug is proposed to be manufactured and marketed in India.” The criteria are a little broader than that suggests, though. CDSCO clarifies that the fast track is open to “novel drug delivery system of new drugs with significant improvement in terms of safety, efficacy,” as well as new biological and chemical entities.
Other sections of the document explain that clinical trial sites that lack an internal ethics committee must seek clearance from an ethics committee based within a 50 km radius and set out when the authorities may waive the requirement for local trials of a new drug already approved overseas.
TGA Links Upscheduling to 50% Drop in Codeine Medicine Supplies
Australia’s Therapeutic Goods Administration (TGA) saw a 50% drop in shipments of codeine last year after it upscheduled the painkiller. Sales of codeine-containing drugs by volume fell by around 50% in 2018 following the decision to prohibit over-the-counter (OTC) sales of the products.
Until February 2018, Australian consumers could buy drugs containing low doses of codeine without a prescription. The products combined codeine with paracetamol or nonsteroidal anti-inflammatory drugs. Then, TGA made such products prescription only on the strength of an analysis that found the combinations were no better than codeine-free products and had greater health risks.
TGA sourced data from IQVIA to assess the impact of the regulatory change. In 2018, Australian shipments of codeine-containing medicines totaled 17.1 million packs. That compares to an average of 34.7 million over the four previous years.
Around 1.8 million of the packs supplied last year were traded in January, before the ban came into effect, suggesting the figure for 2018 as a whole may be slightly higher than sales going forward.
TGA sought to eliminate the influence of the one month of OTC sales in an analysis of the weight of codeine shipped last year. In the 11 months following the OTC ban, 8,254 kg of codeine was supplied in Australia. A forecast based on earlier years suggests shipments would have totaled 15,213 kg had TGA not upscheduled the drug, suggesting supplies fell by 46% as a result of the ban.
In the run up to the OTC ban, there were concerns that patients would switch from low to high-dose codeine medicines when they were unable to source the former without a prescription. TGA found little evidence to support those concerns in its data.
From February to December 2018, 7274 kg of high-strength 30 mg Schedule 4 codeine was supplied in Australia, compared to 6816 kg over the same period of the previous year. While that means more high-dose codeine was shipped following the ban on OTC sales, the difference fell short of statistical significance, leading TGA to conclude its analysis does not support the concerns.
TGA is currently analyzing the IQVIA data alongside information from other sources, including the Pharmaceutical Benefits Scheme, to better understand the effects of upscheduling. One important point not addressed in the analyses of sales data is whether the upscheduling led to a reduction in adverse events.
WHO Seeks Consultant to Help Cambodia Strengthen Drug Regulation
The World Health Organization (WHO) is recruiting a consultant to help Cambodia improve its drug regulatory system. WHO will task the short-term consultant with advancing Cambodia’s systems for medicines regulation and supply management in line with the current strategic plan for the sector.
Cambodia drew up a strategic plan for the next five years of its pharmaceutical industry in 2012. Yet, having come to the end of the period covered by the plan, WHO thinks “various components of the system still need to be strengthened.” This year, Cambodia plans to revise the laws and regulations covering pharmaceuticals and make other changes to resolve the shortcomings of the system.
To support those efforts, WHO has issued a tender for a short-term consultant. The consultant will work under the direction of WHO’s office in Cambodia on a range of tasks, including development of regulatory norms, standards and guidelines. WHO plans to adapt local and international guidelines.
WHO has already begun a gap analysis of pharmaceutical laws and regulations, but wants to enlist a consultant to help with other tasks. The WHO roadmap foresees the evaluation of the 2013 to 2018 strategic plan, the drafting of a new document covering the next five to 10 years and the creation of a legal framework for pharmaceutical legislation.
CDE Shares Chinese Medicine Clinical Research Guidelines for Consultation
China’s Center for Drug Evaluation (CDE) has published six draft technical guidelines about the clinical development of traditional medicines. The guidelines cover the development of traditional Chinese medicines in the treatment of conditions including chronic constipation and diabetic kidney disease.
Since 2016, China has revised and adopted tens of traditional medicine guidelines. The latest set of draft documents address indication-specific considerations for development programs.
In the guideline on chronic constipation, CDE defines the condition and the positioning of traditional Chinese medicines within the treatment pathway, before going on to address points including the inclusion/exclusion criteria, the use of active comparators and the main indicators of efficacy.
The Chinese agency covers similar ground in documents about constipation in children and diabetic foot disease, kidney disease, retinopathy and peripheral neuropathy.
CDE is accepting feedback on the drafts until 4 August.
has released materials to help healthcare professionals understand changes to medicine labels. The revised labels, which will trickle into real-world use over a four-year transition period, are designed to be more consistent and more clearly convey important information. TGA thinks these changes may reduce medication errors. TGA Notice
is to stop accepting safety update reports from research and development programs on paper. CDE laid the groundwork for the change by creating a way for companies to file reports electronically. CDE Notice