Asia Regulatory Roundup: India Gives Device Manufacturers Another Year to Meet Drug Regulations

RoundupsRoundups | 07 January 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India Gives Device Manufacturers Another Year to Meet Drug Regulations
India has extended the transition to new rules for certain medical devices by 12 months. Regulators were due to start treating a clutch of devices as drugs on 1 January, but have given the industry more time to adapt.
Details of plans to treat more devices as drugs for regulatory purposes, thereby increasing oversight of the products, emerged in December 2018. At that time, the Indian government said it would treat nebulizers, blood pressure monitors, digital thermometers and glucometers as drugs from the start of 2020 onward. Later, the government vowed to treat imaging equipment as drugs from April 2020.
Neither deadline will be enforced. Days before it was due to start applying the new regulatory regime to nebulizers and the other three device classes, the Indian government pushed back the deadline to January 2021. In a separate notice, the government delayed the imaging deadline to April 2021.
The delays follow shortly after the Indian government published draft legislation that would increase regulatory oversight of all types of medical device. That legislation featured an 18-month transition period. It is unclear if the broader move to increase oversight of medical devices will be affected by the delays to the enforcement of the rules on certain classes of product.
Gazette Notification, More
TGA Relaxes Rules on Some Antimicrobial Lozenges After Pilot Project
Australia’s Therapeutic Goods Administration (TGA) will permit some antimicrobial throat lozenges to be regulated as listed products after concluding a pilot assessment of the impact of the change. The new regulatory flexibility applies to three active ingredients in certain indications.
TGA began assessing whether the oversight of certain low-risk registered products is still appropriate upon the recommendation of experts who reviewed Australian regulations in 2015. The process led to a pilot project covering amylmetacresol, benzyl alcohol, cetylpyridinium chloride, dichlorobenzyl alcohol and hexylresorcinol, active ingredients used in antimicrobial throat lozenges.
After analyzing publicly available safety data, TGA concluded benzyl alcohol, cetylpyridinium chloride and hexylresorcinol can be regulated under the less onerous listed product regime. TGA found too little data to support relaxing the rules on the other two active ingredients.
The change comes with some caveats. TGA will only class lozenges as listed medicines if “specific restrictions regarding duration of use, maximum daily dose and label warnings regarding use in pregnant or lactating women” are applied. Manufacturers of listed lozenges will also be unable to market their products as having an antibacterial, antiseptic or anaesthetic action.
Manufacturers of affected lozenges can either retain their current registration or cancel it, provided they certify that their product meets the listed medicine requirements.
TGA Statement
Smoke Forces TGA to Close Office, Limiting Telephone Communications
TGA has closed an office and relocated staff in response to air quality problems created by fires in Australia. The closure of the office has limited telephone access to TGA.
The closed office is in Symonston, a suburb of the Australian capital of Canberra. In recent weeks, large areas to the east and west of Canberra have suffered bushfires, causing smoke to engulf the city. Last week, the air in Canberra was more polluted than in any other city on earth. On the first day of 2020, pollution levels were 34 times higher than World Health Organization guidelines.
Since then, pollution levels have fallen somewhat but the situation remains serious enough for TGA to close its Symonston office. TGA said the office will remain closed and staff relocated until further notice. The Department of Health said its Symonston office will be offline until 9 January.
TGA expects the office closure to affect its operations, specifically its interactions with stakeholders. In disclosing the closure, TGA said its “telephone lines currently have limited operations,” adding that it wants people who are trying to contact it to, “Please bear with us and we’ll try to answer your call as soon as possible.”
TGA Notice, The Guardian, More
ASEAN Adds Philippine FDA to GMP Mutual Recognition Program
The Philippine Food and Drug Administration (FDA) has joined a regional mutual recognition program. As part of the Association of Southeast Asian Nations (ASEAN) initiative, the Philippine FDA’s good manufacturing practice (GMP) inspection reports will be accepted by other regional agencies.
ASEAN members signed the GMP mutual recognition agreement (MRA) in 2009 to facilitate the use of inspection reports across the 10-country bloc. Only regulatory agencies that meet Pharmaceutical Inspection Co-operation Scheme standards can provide GMP reports for use by other ASEAN members. Indonesia, Malaysia, Singapore and Thailand were the first agencies to meet that standard.
Now, an ASEAN expert panel has ruled that the Philippine FDA meets the criteria for providing GMP reports for use by other countries. The Philippine FDA thinks companies will benefit from reduced inspections, lower costs, export opportunities and enhanced market access.
FDA Notice
TGA Publishes Guidance on Fecal Microbiota Transplant Products
TGA has released guidance on fecal microbiota transplant (FMT) products. The publication of the guidance follows a public consultation that led TGA to regulate most FMT products as either Class 1 or 2 biologicals.
In the guidance, TGA defines FMT products as things that comprise, contain or are derived from human stools and are introduced into people for therapeutic use. That definition is broad enough to capture fresh and frozen human stools that are introduced to the bowel, for example through a rectal enema, and human stools that are encapsulated for oral ingestion.
TGA regulates most products that meet that definition as Class 1 or 2 biologicals. FMT products that are manufactured at the hospital where the patient is being treated are Class 1 biologicals. Products made off site for use at hospitals and clinics are Class 2 biologicals.
Some FMT products may fall into other, higher-risk groups in the biologicals classification. However, the guidance says little about these products, simply stating that, “All other FMT products will be classified as per information on classification of biologicals,” and linking out to the relevant text.
TGA Guidance
Other News:
TGA has fined Mundipharma over the promotion of Targin opioid medicines to healthcare professionals. According to TGA, Mundipharma “appeared to positively encourage the prescription of Targin medicines for chronic non-cancer pain.” TGA wants to discourage routine opioid use in non-cancer pain, leading it to hit Mundipharma with 24 infringement notices. TGA Notice
India’s Central Drugs Standard Control Organization (CDSCO) is set to hold special public hearings twice a month. The hearings will cover “various issues/queries of applicants/visitors.” CDSCO officers and other staff members will provide input on the matters raised at the hearings. CDSCO Notice
China’s National Medical Products Administration (NMPA) has approved the first vaccines against recombinant human papilloma virus and 13 pneumococcal strains developed by local companies. NMPA thinks the approvals will increase access to vaccines against the virus and bacteria, which are also targeted by prophylactics sold by global companies including Merck and Pfizer. NMPA Notice, More (both Chinese)
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has shared details of a fifth death that may be related to a change in the brand of lamotrigine the victims were taking. Lamotrigine is an epilepsy therapy. New Zealand used to fund three brands featuring the ingredient but stopped covering two of the products over a five-month transition period last year. Medsafe Notice


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