Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Offers Advice on Managing Shortages Triggered by Ranitidine Recalls
Australia’s Therapeutic Goods Administration (TGA) has advised physicians about how to manage the shortages created by recalls of ranitidine medicines. The notice follows decisions by eight companies to recall batches of ranitidine medicines in response to contamination concerns.
TGA first provided information about the potential contamination of ranitidine medicines with the carcinogen N-nitrosodimethylamine (NDMA) last month. Since then, Sandoz and seven other companies have recalled ranitidine medicines, including products TGA describes as “commonly-used brands,” from pharmacies, hospitals, wholesalers and other retailers in Australia.
The result is a shortage of ranitidine tablets and oral liquids. To help physicians manage the situation, TGA issued a notice alerting healthcare professionals to the availability of a discussion of alternative treatment options on the NPS MedicineWise website.
One of the NPS documents covers the management of gastroesophageal reflux disease. TGA notes that H2 receptor antagonists, proton pump inhibitors and diet and lifestyle modifications can all play a role in the management of the disease. The second NPS document addresses the treatment of acid reflux in pregnant women, a population in which TGA thinks physicians should consider alternatives to ranitidine medicines.
TGA issued the notice to help physicians manage the situation while it works to ascertain whether ranitidine medicines sold in Australia pose a threat to patient safety. The agency has now begun to test Australian ranitidine medications for NDMA and plans to publish a detailed report once it has completed the assessments.
Malaysian Regulator Revises Guidance on Drug Registration Process
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has revised its drug registration guide. The updated, 710-page document addresses quality control, inspections and other steps in the drug registration process and features product-specific labeling requirements for eight more therapies than its predecessor.
NPRA introduced the second version of its Drug Registration Guidance document in 2016 and has revised it three times since then. The majority of the document has remained unchanged throughout the revision process, with NPRA using the updates to add new information rather than overhaul the existing text. As such, each version has provided an overview of products covered by the guidance, a walkthrough of the registration process and information about quality control and inspections.
Changes between the January 2019 version of the document and the latest text include the addition of product-specific labeling information for another eight medicines. The latest document has specific labeling information for 221 products.
Beta-lactam antibiotics, including combination products, are among the medicines to be covered by product-specific labeling requirements for the first time. NPRA is requiring manufacturers to add a warning about the risk of “serious and occasionally fatal hypersensitivity reaction.” The agency wants healthcare professionals to make “careful” inquiries whether a patient has previously suffered from hypersensitivity reactions and stop treatment immediately if they respond badly to a beta-lactam.
Other changes include the addition of warnings about the link between hydrochlorothiazide and types of cancer, cases of pathological immune activation in patients taking lamotrigine and the risk of depression in patients taking systemic retinoids.
, Revised Guidance
New Zealand Liberalizes Rules on ALS Medicine to Improve Patient Access
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has relaxed the rules on the use of riluzole in amyotrophic lateral sclerosis (ALS). Medsafe now permits generalist physicians to prescribe the glutamate agonist after consulting with specialists.
Under the old rules, the power to prescribe riluzole was limited to specialist physicians who care for ALS patients, neurologists and palliative care physicians. Medsafe considered changing the rules after being approached by several clinicians who argued the regulations in New Zealand, which were more restrictive than in other countries, were making it harder for patients with ALS, a motor neuron disease, to access riluzole.
The resulting consultation attracted 28 responses, all of which supported permitting generalists to prescribe riluzole in certain circumstances. After seeing the feedback, Medsafe agreed to allow generalists to prescribe the drug when the “decision is taken in collaboration with, or following consultation with physicians who care for patients with motor neurone disease, neurologists and palliative care physicians.”
Medsafe addressed two specific comments in its review of the feedback, although neither caused it to change its plans. One comment argued gerontologists should be included in the list of people who can prescribe riluzole. Medsafe declined to make a change as it felt the original definition implicitly captured gerontologists.
The second comment discussed by Medsafe suggested limiting prescribing powers to generalists with vocational registration, a form of “permanent, specialist registration” that allows physicians to work independently. In its response, Medsafe stated it is important for people in rural areas to have access to riluzole and that its original proposal safely achieves this outcome.
China Approves First PD-L1 Companion Diagnostic, Expands Keytruda Label
China’s National Medical Products Administration (NMPA) has approved Agilent Technologies’ PD-L1 companion diagnostic. The approval marks the first time NMPA has cleared a companion diagnostic for use in the identification of patients whose tumors express PD-L1.
Agilent secured the approval in conjunction with the authorization of Merck’s anti-PD-1 checkpoint inhibitor Keytruda in locally advanced or metastatic non-small cell lung cancer (NSCLC). The Keytruda authorization permits the use of the antibody as a monotherapy in first-line settings, provided the patient’s tumor expresses PD-L1 and lacks EGFR or ALK genomic aberrations.
Merck partnered with Agilent to develop a companion diagnostic to provide physicians with the PD-L1 information they need to decide whether to prescribe Keytruda in first-line NSCLC patients.
Keytruda came to market in China around one year ago and is now authorized in three indications in the country. The latest authorization was based on overall survival data from a global Phase III trial, which featured an extension in Chinese patients. Patients who received Keytruda as a monotherapy lived longer than their peers in the chemotherapy cohort.
, Merck Statement
’s Central Drugs Standard Control Organisation
(CDSCO) has shared details of the laboratories cleared to test medical devices and in vitro
diagnostics (IVDs). CDSCO posted a list of four organizations that can test certain medical devices and sent a separate notice about evaluating IVDs to 25 healthcare centers. Both texts relate to the medical device rules that India implemented at the start of last year. Device Notice
, IVD Notice
has provided an update on its advertising case against Auzsupps
, a supplement supplier. The agency said Auzsupps has complied with the direction it provided in August. TGA told the company to stop advertising products that contain Schedule 4 substances including selective androgen receptor modulators on its website and social media channels. TGA Update
has outlined steps to “strengthen the process of regulatory guidance” from units dedicated to different aspects of healthcare. Officials from the divisions will be available at the public relations office at CDSCO’s headquarters at set times of the week. For example, the industry can interact with the medical device team on Monday morning. CDSCO Notice
has shared a safety advisory about the increased risk of death in some gout patients when taking febuxostat. The warning follows research showing gout patients with pre-existing major cardiovascular disease had a higher risk of death when taking febuxostat compared to allopurinol, another treatment for the condition. TGA Notice