Asia Regulatory Roundup: Shortage Mitigating Measures Increase After TGA Moves to Mandatory Reporting

RoundupsRoundups | 03 March 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Shortage Mitigating Measures Increase After TGA Moves to Mandatory Reporting
Australia’s Therapeutic Goods Administration (TGA) approved more requests to import medicines from overseas to counter supply disruptions after the adoption of mandatory reporting requirements for potential shortages.
Legislation requiring manufacturers to report shortages and discontinuations of prescription drugs and over-the-counter medicines in Australia came into force at the start of 2019. Last week, TGA presented data to show the effect of the legislation on the reporting of medicine shortages and actions to mitigate their impact on patients.
TGA received 290% more shortage notifications last year than in 2018. More than 90% of companies consented to the publication of their shortage notifications. Three-quarters of companies consented straightaway, with the remainder doing so after talking to TGA.
There are signs the increase in notifications may be affecting how the industry responds to supply disruptions. Last year, TGA approved 113 applications to import medicines not listed in the Australian Register of Therapeutic Goods to mitigate a shortage. The figure represents a 40% increase over the prior year.
What, if any, effect the mandatory reporting had on the number of import requests and approvals is unclear. The number of import applications approved by TGA has ticked up in recent years, rising from below 60 in 2017 to above 80 the following year. That trend accelerated last year.
TGA has identified ways to better maintain drug supply by engaging with stakeholders through the Medicine Shortages Working Party. Based on the discussions, TGA sees scope to increase the proportion of notifications that companies allow to be published, make health professionals more aware of drug shortage information and better forecast supply disruptions.
The agency also plans to provide manufacturers with more information about the process for seeking approval to import medicines from overseas to mitigate a shortage. TGA thinks the information can help to cut the time it takes to enact contingency measures.
TGA Report
Philippine FDA Publishes Pharmacovigilance Guidelines to Clarify Existing Texts
The Philippine Food and Drug Administration (FDA) has published pharmacovigilance guidelines. The text is intended to clarify earlier pharmacovigilance documents, which were criticized for providing unclear advice on reporting mechanisms and timelines.
In light of the perceived shortcomings of existing documents, such as a circular covering postmarket surveillance of authorized drug products, the Philippine FDA has created a new guideline. The agency developed the document to “provide clear guidelines for market authorization holders on their pharmacovigilance requirements for all registered drugs and biological products for human use.”
The guideline seeks to clear up the confusion about reporting mechanisms and timelines. Officials expect companies to submit reports of serious adverse reactions within 15 calendar days, regardless of whether the event was expected or not. The clock starts when a member of staff at the company first learns of the adverse reaction.
Philippine FDA officials have also set out the minimum information companies need to include in their submissions. The agency wants companies to provide details of the patient, the reaction they had, the product or products that may have caused the adverse event and information about the person who reported the incident. Failure to include each element will render a filing incomplete and ineligible for submission.
Elsewhere in the guideline, the Philippine FDA discusses risk-management plans, periodic benefit-risk evaluation reports and the need to disclose recalls and other actions taken by foreign regulators within 72 hours.
The Philippine FDA plans to inspect companies to ensure their systems comply with the guidelines. In most cases, the agency will inform the company about the inspection in advance. However, the agency “reserves the right to conduct unannounced inspections, if necessary.” Companies found to be noncompliant with the rules face a range of possible penalties including fines and the cancellation of licenses issued by the agency.
FDA Guidelines
Australia Starts Independent Review Into Effectiveness of Recent TGA Reforms
Australia has begun an independent review into advertising reforms recently implemented by TGA. The review will assess the impact of changes including amendments to the Australian advertising code.
In February 2018, the Australian government vowed to review the advertising measures within two years of the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018 taking effect. Now, the promised review has gotten underway under the leadership of Rosemary Sinclair, an Australian with senior governance experience in highly regulated sectors other than healthcare.
The review will assess whether changes to the advertising code have “increased clarity and objectivity,” and look at the impact of making TGA the single body responsible for handling complaints about advertising. Other objectives include reviewing the impact of new sanctions and penalties for noncompliance and the effectiveness of the Therapeutic Goods Advertising Consultative Committee (TGACC).
Depending on what the review finds, it may also recommend making further changes to the regulation of therapeutic goods advertising, including the processing of complaints. To assess whether such actions are needed, Sinclair and her collaborators will talk to the Pharmaceutical Society of Australia and other members of the TGACC.
TGA Notice
India’s CDSCO Permits Simultaneous Submission of Registration and Import Filings
India’s Central Drugs Standard Control Organization (CDSCO) has changed its procedures for seeking registration certificates and import licenses. CDSCO now permits companies to file for the clearances simultaneously.
Companies that want to import drugs into India need to register the manufacturing sites that make the products with CDSCO. For new medicines, companies need to obtain permission under the New Drugs and Clinical Trials Rules, 2019, before getting the registration certificate and import license.
The need to seek clearances in sequence has caused frustrations among importers, leading them to call for CDSCO to support the simultaneous submission and processing of applications. CDSCO has now agreed to the request.
“The applicant can submit its application for obtaining registration certificate and import license simultaneously, while submitting the application for permission for import of any new drug in the country,” CDSCO wrote in a notice to disclose the change.
CDSCO will process the applications simultaneously and grant the registration certificate and import license “subject to condition of issuance of the new drug permission” under the 2019 legislation.
CDSCO Notice
Philippine FDA Finds More Counterfeit Versions of Sanofi’s Rabies Vaccine
The Philippine FDA has issued another warning about counterfeit versions of Sanofi’s rabies vaccine Verorab. Last year, the FDA posted back-to-back warnings about fake copies of Verorab and a rabies vaccine sold by GlaxoSmithKline.
Sanofi worked with the regulator to confirm that suspect packs of Verorab are counterfeit. Having done so, the FDA published details of how to identify counterfeits, noting that the box is of a poor quality, the vial label is a bright red, rather than the dull color found on genuine products, and the label on pre-filled syringes is inverted.
The warning is the third time in less than nine months that the FDA has issued notices about the distribution of counterfeit rabies vaccines. In July, the regulator shared details of fake copies of Verorab and GSK’s Rabipur.
FDA Notice
Other News:
The Philippine FDA’s Center for Device Regulation, Radiation Health, and Research is set to start receiving applications based on the Association of Southeast Asian Nations (ASEAN) harmonized technical requirements on 13 March. The change builds on a 2014 ASEAN agreement. FDA Notice


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