Asia-Pacific Roundup: Medsafe updates overview of new and ... - Regulatory Focus

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has released a new version of its overview of medicine regulation in the country. Medsafe published the document after carrying out a major review and restructuring of its advice on the approval of new and changed medicines.
 
While large sections of the guideline remain unchanged, Medsafe has added a new, short section on how to submit an application or notification, explaining that applications must be sent electronically and outlining how to use an electronic file transfer system to share files. The transfer system enables the submission of applications, notifications and master files to the agency.
 
Medsafe also has updated the list of what it expects sponsors to have to ensure the supply of safe and effective medicines and timely responses to stakeholders. The list now includes staff available in New Zealand business hours to engage with Medsafe on quality issues; arrangements with overseas suppliers to ensure the dossier accurately reflects the product marketed in New Zealand; and procedures to routinely monitor Medsafe's website to ensure timely response to communications or consultations.
 
The simplified text was published as New Zealand prepares for the biggest changes to how it regulates medicines and medical devices in years. Late last year, The Therapeutic Products Bill was introduced to Parliament. The Bill, which is still open for comment, is intended to modernize the regulatory regime and replace a framework that the government sees as "out of date, not fit for purpose, inflexible and increasingly out of step with comparator countries."
 
Medsafe Guideline
 
Philippine FDA proposes expanding compassionate rules to cover emerging infectious diseases
 
The Philippine Food and Drug Administration (FDA) is seeking feedback on plans to update its guidelines on the compassionate use of unregistered or unauthorized therapeutic goods.
 
Physicians can administer therapeutic goods on a compassionate-use basis in the Philippines under an administrative order published in 1992. However, the original order imposes limits on the scope of compassionate use that officials have subsequently sought to tweak, first in 2015 with a text focused on medical devices, and later in 2020 with a policy influenced by the COVID-19 pandemic.
 
Now, FDA has proposed updated guidelines that reflect the evolution of the scope of the rules. Notably, the guidelines support the compassionate use of vaccines against emerging and re-emerging infectious diseases.
 
"Many of these diseases do not yet have any cure, and healthcare providers are also often victims of such diseases. Immunization reduces the risks of getting a disease and are critical to the prevention and control of infectious disease outbreaks," the regulator wrote. FDA sees value in allowing the use of vaccines when no treatment alternatives exist and the benefits outweigh the risks.
 
Emerging and re-emerging infectious diseases join AIDS, cancer, life-threatening conditions, diseases that may lead to permanent medical impairment and rare diseases on the list of conditions covered by the compassionate-use rules. Companies can seek compassionate-use permits for products that lack a valid FDA registration or authorization, and, in certain circumstances, for investigational drug products.
 
The guideline explains the conditions and requirements for compassionate use. Applicants must submit details of the patient and the physician making the request. If the request covers a vaccine, the applicant must provide a report of the benefit-risk assessment in the proposed recipient. Applicants need to make post-approval reporting commitments, the specifics of which vary depending on the type of therapeutic good covered by the compassionate-use permit. 
 
FDA is accepting feedback until 9 February.
 
Draft Guidelines
 
Singapore HSA seeks feedback on planned cybersecurity labeling scheme for medical devices
 
The Health Sciences Authority (HSA) and other agencies in Singapore have begun a consultation into the proposed cybersecurity labeling scheme (CLS) for medical devices.
 
In recent years, the Cyber Security Agency of Singapore (CSA) has established a CLS for smart consumer devices to improve the security of the Internet of Things. Now, CSA has worked with other agencies and industry representatives to create CLS(MD), a related initiative targeted at medical devices that handle personal identifiable information and clinical data and connect to other devices, systems and services.
 
The draft CLS(MD) proposal describes a four-tier cybersecurity rating scale. To achieve level 1 status, a company will need to at least meet the four cybersecurity requirements that HSA already imposes when registering medical devices in Singapore. HSA is seeking feedback on plans to add two additional clauses, about passwords and preventing brute force attacks, to the level 1 requirements,
 
Level 2 features 38 additional cybersecurity clauses, but still only requires the applicant to submit a declaration of conformity for review by CSA. To achieve levels 3 and 4, companies need to undergo independent third-party testing.
 
At level 3, medical devices will undergo "one-month time-bound black-box penetration testing" to prove that they are "reasonably resistant to common attacks" and that there are "no obvious or critical vulnerabilities." Medical devices must withstand a three-month white-box security evaluation to achieve level 4, a status that indicates a product is resistant to "more moderately complex attacks."
 
Manufacturers label their products with their CLS(MD) levels for products sold to non-qualified medical or dental practitioners. Affixing the labels to professional-use only devices is optional. The labels are valid for three years, during which time the developer needs to deliver security updates as required. Officials can revoke labels if certain conditions are not met. 
 
The consultation closes on 3 March.
 
HSA Notice
 
Philippine FDA starts consultation into new schedule of fees for certain health equipment
 
The Philippine FDA is seeking feedback on a revised schedule of fees for health-related devices including products for handling sharps and pathological and infectious wastes.
 
In 2020, FDA published revised guidelines designed to simplify the requirements and processes for initial, renewal and variation license to operate (LTO) applications. The 2020 guideline required manufacturers, traders and distributors of health-related devices to obtain a LTO. FDA's schedule of fees for health-related devices dates back to 2001.
 
The latest proposal will bring the fee schedule up to date. FDA has proposed different fees for initial and renewal filings. The fees range from 3,000 to 20,000 Philippine pesos ($54 to $366), with the highest fees reserved for larger operations and renewal filings with a two-year validity. 
 
FDA is accepting comments on the proposals until 9 February.
 
FDA Notice
 
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Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has published an English-language version of a good clinical practice document that was originally released last year. The Ministerial Ordinance covers standards for preparing, managing and conducting clinical trials. Ministerial Ordinance