Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Philippines to Take ‘Drastic’ Actions to Wipe out Backlog of Applications
The Philippines Food and Drug Administration (FDA) has committed to “drastic” actions to deal with its backlog of applications. Agency chief Nela Charade Puno plans to clear the backlog by waving through applications that have been pending for six months or more and then setting up a system that stops the bottleneck from reoccurring.
Puno inherited an extensive backlog when she took over as director general of the Philippines FDA in 2016. Since then, Puno’s FDA has taken some steps to try and get the situation under control, but the problem continues to affect the agency and the companies its serves. The agency still has around 80,000 applications pending that appear “to have been at the FDA for close to a decade and have been left unattended,” Puno said. With her tweaks failing to wipe out the backlog, Puno has decided to take more drastic actions.
“Starting September this year, applications for license to operate and product registration pending with the FDA for a period of six months or more will be approved provided they have fully complied with the requirements, including the payment of fees,” Puno said. These actions are expected to clear around 80% of the applications from the backlog.
The idea is to temporarily shift the assessment burden from pre to post-approval. Rather than check all the filings before granting permits or certificates of product registration, the FDA will sign off on them if they meet the basic requirements and then subject the companies to greater post-approval monitoring. Puno thinks the extra post-approval monitoring will ensure the health and wellbeing of the public are protected, although that will also require resources.
Officials expect to finish waving through the old applications by the end of the year. After that, Puno and her team will stop automatically signing off on applications that are older than six months. The one-time removal of old applications from the system is intended to wipe the slate clean so Puno can establish a better process that keeps filings flowing.
The size of the current backlog is partly a function of the “inability of applicants to submit product registration requirements,” Puno said. Under the revised, incoming system, the Philippines FDA will automatically reject filings from applicants that fail to submit all the required materials within a set amount of time. This harder line is intended to keep “nuisance” applications out of the backlog. Puno is also trying to stamp out corruption at the FDA, in part by encouraging applicants to speak up when an official jeopardizes the efficiency or integrity of the approval process.
Puno said the new system could fix problems that are downstream of the backlog. Notably, Puno thinks the proliferation of unapproved medicines in the Philippines stems from the long time it takes to get products on the market through official channels. If the FDA approves drugs in a reasonable timeframe, more companies may eschew the black market, raising the standard and oversight of drugs sold in the Philippines.
Korea’s Financial Regulator Rules Samsung BioLogics Intentionally Breached Standards
South Korea’s Securities and Futures Commission (SFC) has ruled that Samsung BioLogics breached its accounting standards. The financial regulator wants to punish Samsung BioLogics for the violations by removing executives and referring the case to prosecutors.
SFC found Samsung BioLogics had intentionally omitted information about its joint venture with Biogen from public disclosures. That finding led SFC to approve multiple punitive actions against Samsung BioLogics, including a request for the dismissal of the executives in charge and designation of external auditors for the next three years. SFC will also refer the case to prosecutors.
The events at the center of the case date back to 2015, when Samsung BioLogics started using a different method to value its biosimilar joint venture with Biogen. Samsung BioLogics said it took the action in response to Biogen’s plans to increase its stake in the joint venture. The Korean wings of Deloitte, KPMG and PricewaterhouseCoopers approved the change. However, with the adoption of the new valuation method preceding a swing to profitability at a pivotal moment for the broader Samsung group, observers questioned the company’s motives and probed the legality of the change.
Several years later, SFC preliminarily concluded that Samsung BioLogics had breached its rules. Samsung BioLogics responded by threatening to sue SFC once the financial regulator reached its final conclusion. Now, SFC has finalized its ruling, reaffirming its belief that Samsung BioLogics breached the rules.
, Samsung Update
TGA Takes Steps to Mitigate Neuropsychiatric Risks of Asthma Drug Singulair
The Therapeutic Goods Administration (TGA) of Australia has taken actions to mitigate the risks of using asthma drug Singulair. TGA implemented the risk-mitigation measures in response to evidence linking the leukotriene receptor antagonist to neuropsychiatric events.
Regulators have known about a possible association between leukotriene inhibitors such as Singulair and neuropsychiatric adverse events for more than 10 years. Interest in the association intensified last year when the media picked up on an academic review into the link between montelukast — the active ingredient in Singulair — and adverse events including depression and nightmares. That led TGA to ask the Advisory Committee on Medicines (ACM) to review the safety of montelukast.
In response to ACM’s findings, TGA has asked health departments in Australia to discuss the link between montelukast and neuropsychiatric events in their guidelines and educational activities. TGA has also asked sponsors to include information about the link in their packaging, and contacted the Australian Paediatric Surveillance Unit to encourage the collection of data on the association.
The actions affect Merck’s Singulair and generic medicines with the same active ingredient.
Malaysia Warns of Fraudsters Pretending to be Regulators
The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has warned that fraudsters are using its name to seek donations and sponsorship. NPRA distanced itself from the activities and told people to be alert for the fraudsters.
To cut the risk of being duped, NPRA is telling people to be wary of communications via phone or letter. The agency is also promoting a phone number people can call if they have doubts about whether it or a fraudster is behind a communication.
The NPRA warning is one of many issued by regulatory agencies around the world in recent years. The details of the warnings vary, but at heart they all relate to people falsely using a regulator’s name to extract money from others.
The Philippines FDA
has started to migrate to a cloud IT system. The migration meant the FDA Inventory System, e-portal, Zimbra and the FDA Inventory System were offline for half a day this week. The FDA thinks moving from its own servers to those run by a cloud infrastructure provider will ultimately improve the service it provides to the industry. FDA Notice
The New Zealand Medicines and Medical Devices Safety Authority
(Medsafe) is hiring a team leader for its medicines assessment unit. The new hire will play a central role in assessments of the quality, safety and efficacy of new and revised medicines. Medsafe is accepting applications until 22 July. Medsafe Notice