Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Unveils Reforms to Simplify Supply Chains, Lower Drug Costs
China has unveiled reforms designed to drive down the cost of drugs while simplifying the supply chain between manufacturers and patients. The proposed model requires manufacturers to sell to a distributor that then sells to the medical institution, as opposed to having a product pass through multiple supply chain players on route to patients.
Officials think this will lower prices. Currently, a chain of distributors and wholesalers move drugs from manufacturers to medical institutions. As each company needs to make money from handling products, it buys at one price and sells at another, higher price. Therefore, officials think the more organizations that handle a drug on its route from the production plant to patients, the higher the end price will be. The incoming model will mean only one distributor needs to take a cut and, so the thinking goes, drug prices will come down.
China Food and Drug Administration (CFDA) published an overview of the proposed procurement changes this week. The regulator is hoping to see the approach adopted nationwide in 2018. Work on trial implementations will step up this year. The plan for the trial is to have 200 public hospitals in 11 provinces adopt the two-step supply chain, Xinhua reports.
This 11-province trial follows a smaller-scale test of the model in Fujian. That initiative started in 2012. Yet, while the Fujan trial led China to propose widespread adoption of the model, some observers are skeptical about whether the results justify the expansion. Writing late last year, FT Chinese reported the cost of vitamin D in Fujian as evidence the two-step supply chain had failed to control drug prices in the region.
These dissenting voices appear to have lost the debate, though. The document released by CFDA calls for manufacturers, distributors, medical institutions and local authorities to take steps to prepare for the implementation of the two-step supply chain.
CFDA Notice, Xinhua, FT Chinese (all Chinese)
DCGI Restates Antibiotic Regulations Following Report of Resistance-Related Death
The Drug Controller General India (DCGI) has restated regulations covering the use of antibiotics following media reports of a drug resistance-related death. DCGI GN Singh took the action to remind regulators, healthcare professionals and patients of the need to control use of antibiotics.
None of the messages conveyed in the notice to regulators and associations representing pharma companies and consumers are new. However, DCGI Singh felt compelled to restate the regulatory requirements after the death of a woman in Nevada, United States, put India's attempt to stop the emergence of antibiotic-resistant bacteria in the global spotlight.
The 70-year-old person died from an infection that was resistant to 26 different antibiotics. The news was widely reported in India, in part because the woman spent two years in the country and is thought to have contracted the infection while there. During her stay, the woman broke her femur and subsequently developed a bone infection that caused her to be hospitalized multiple times.
Testing by the US Centers for Disease Control and Prevention attributed the resistance of the infection to treatment to the presence of New Delhi Metallo-beta-lactamase-1 (NDM). The enzyme is named after New Delhi, because it was first found in a Swedish patient who traveled to India. Researchers have since detected NDM in multiple countries, including Pakistan, where the first death related to the enzyme was recorded.
To minimize the risk of further deaths from drug-resistant strains of bacteria, DCGI Singh wants organizations in the supply chain to comply with labeling requirements for prescription-only drugs. Details of the label vary depending on whether a product falls into Schedule H or H1, but in both cases the intent is to convey that the drug can only be sold with a prescription. Schedule H1 products feature a warning, highlighted by a red box, that it is dangerous to sell them "except in accordance with the medical advice."
Despite this, India still has work to do to get the message across. DCGI Singh wants officials to take "strong policy measures including stringent regulatory action" to stop over-the-counter sales of antibiotics. In parallel, DCGI Singh is calling for an awareness campaign about the side effects of taking antibiotics without a prescription.
DCGI Notice, STAT
CFDA Drafts Guidance to Standardize Naming of Chinese Medicines
CFDA has released draft guidance intended to standardize the naming of Chinese medicines. The objective is to ensure all traditional Chinese medicines have short, scientific, unambiguous names that do not make claims about the efficacy of the product.
Officials have used the guidance to establish some basic principles for the naming of Chinese medicines. CFDA wants to limit the length of names to eight words or fewer. Clear, scientific words are favored.
CFDA has also detailed types of words that are prohibited. Vulgar language, business names and words related to celebrities will be banned under the guideline. Words denoting pharmacological effects, such as "lipid-lowering" and "anti-inflammatory," and layman language implying efficacy are also forbidden.
If adopted, the guidance will affect all traditional Chinese medicines, regardless of whether they are new to the market or well established. In the case of established products, CFDA will allow the use of long-standing but now non-compliant names during a transition period. Ultimately though, all products must comply with the requirements.
The draft is open for feedback until 15 February.
Draft Guidance (Chinese)
TGA Releases Declaration of Conformity Templates for IVDs
The Therapeutic Goods Administration (TGA) of Australia has published templates to help manufacturers of in-vitro diagnostics (IVDs) meet declaration of conformity requirements. TGA has released five templates covering different aspects of the regulatory process.
Manufacturers of IVDs must make the declarations to state their medical devices comply with applicable provisions of the essential principles, classification rules and an appropriate conformity assessment procedure. TGA also expects manufacturers to submit details of relevance to the conformity assessment procedure and production of the IVD.
To help manufacturers submit all the required information in a clear format, TGA has created templates. These documents feature the necessary boilerplate text and gaps for manufacturers to add details relevant to their IVD and operation. The five templates cover the declaration of conformity itself and specific details, such as the full quality assurance procedure and production quality management system.
TGA is warning manufacturers that, regardless of whether they use a template, they are responsible for ensuring their declarations of conformance of "drawn up correctly" and meet legal requirements.
CFDA has released guidelines on the clinical evaluation of magnetic resonance imaging (MRI) systems. The MRI guideline is one of four documents on medical equipment released by CFDA. The other documents cover equipment and techniques including defibrillators and computed tomography. CFDA Notice (Chinese)
The Central Drugs Standard Control Organization (CDSCO) has released a list of officials qualified to conduct vaccine inspections. All 35 of the officials have at least 18 months of experience in manufacturing or testing, or three years of experience of inspecting production plants. The officials all also meet four other requirements. CDSCO List
TGA has adopted a batch of European Union guidelines following a consultation. The documents include texts on the pharmacokinetics and pharmacodynamics of antimicrobials and multiple product-specific bioequivalence guidelines. TGA Notice