Asia-Pacific Roundup: Singapore’s HSA finalizes LDT guidelines
Singapore’s Health Sciences Authority (HSA) has finalized guidance intended to help clinical laboratories understand the regulatory requirements for tests they develop internally.To date, HSA has not directly overseen laboratory-developed tests (LDTs) – those tests developed in-house by Ministry of Health licensed laboratories for clinical diagnostic use solely within their own facilities. HSA now thinks it needs to regulate LDTs to ensure they meet essential manufacturing and efficacy standards.
Its 22-page guidelines feature examples of test systems that do and do not meet the definition of LDT. HSA does not classify research-use only tests and commercial IVDs that are used off-label or in modified procedures as LDTs. The guideline is informed by feedback received during a consultation held in summer.
The guidelines also provide an overview of the regulatory controls for LDTs. The authority divides the controls for LDTs into three categories: product controls, manufacturing quality controls and post-market controls.
Laboratories that use LDTs need to “implement and maintain an appropriate quality management system in their facilities in relation to their manufacturing activities ... to ensure that all batches of LDTs (i.e. products) they manufacture continue to meet consistent quality and performance specifications (e.g. accuracy, reproducibility).” The laboratories do not need to obtain a manufacturing license from HSA.
The entire LDT design and manufacturing process should be carried out under a quality management system, such as ISO 13485, ISO 15189 or another relevant and equivalent accreditation program. HSA expects labs to document the process, including quality control steps and measures implemented during design, manufacturing and other stages.
Postmarket, laboratories need to report adverse events and recalls associated with their LDTs to HSA, which will monitor the progress of investigations conducted in response. The guidelines discuss what needs reporting, explaining that, in general, “any incorrect results, discrepant results and/or errors (instrument, reagent) detected after [the] patient’s result has been reported, should be reported as an [adverse event].”
The final guidelines will take effect on 1 March.
Final Guidelines
Philippine FDA seeks feedback on regulatory reliance, responses in health emergencies
The Philippine Food and Drug Administration (FDA) is holding consultations on its approach to relying on other regulatory agencies and its powers during national health emergencies.
FDA has published draft guidelines on establishing the principle of reliance, defined as an agency considering the assessment of a peer agency when making decisions, as well as in its processes. The goal is to accelerate the evaluation of authorization applications, to improve efficiency by eliminating duplicative work and to “optimize innovative and more effective forms of international collaboration.” FDA expects all stakeholders to benefit from the initiative.
“Effective implementation of reliance will benefit not only the agency but also the patients/clients, healthcare providers, marketing authorization holders and other stakeholders,” the draft guidance states. “This will consequently strengthen postmarketing surveillance and promote continuous improvement in building FDA’s institutional capacity towards effectively safeguarding public health.”
The guidelines feature defining principles for regulatory reliance, explaining that “procedures shall be coherent with the FDA’s overall legal frameworks” and supported by clear regulations to ensure effective implementation. FDA, while being open to work-sharing opportunities, shall build its own competency for “critical decision making and proper implementation.”
may apply the approach to pathways that allow “recognition of relevant regulatory decisions, assessment reports [and] inspection reports,” as well as to decisions about laboratory testing, clinical trials and lot release. The scope of the approach also covers the establishment of pathways that expedite the review of products during public health emergencies.
FDA provided more information on its handling of public health emergencies in a separate draft. In the document, the agency provides details of the power of the Philippine president to suspend FDA requirements and streamline authorizations during national public health emergencies.
Philippine legislation already grants the president powers including the ability to suspend or waive the requirements for getting permits, licenses, clearances, certifications or authorizations during public health emergencies. The draft guidelines outline how FDA will respond to emergencies, explaining that it will convene a crisis management committee within 24 hours of the declaration of a public health crisis or the president’s use of their powers.
Reliance Draft, Emergencies Draft
Pakistan’s DRAP starts consultation on new risk-management approach to inspections
The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on converting its inspection work to a risk-management approach “capable of revealing weaknesses and deficiencies in the production, quality control, storage or distribution of therapeutic goods.”
In draft guidance on the topic, DRAP outlines processes intended to achieve that goal and to devise “uniform procedures for taking regulatory actions and handling of products with suspected quality defects or identified as substandard and falsified.” The draft describes the duties of federal inspectors and the procedures covering the execution of their powers. For example, the text lists the paperwork inspectors need to complete when taking samples or sealing a factory.
Another section describes a risk-based approach to good manufacturing practice (GMP) inspections. The regulator plans to use international guidelines on quality risk management to categorize facilities by risk. All facilities will undergo GMP inspections at least every three years, with some sites visited more often based on their risk categorization.
DRAP’s risk-based panel will be able to take samples and forbid facilities from removing or dispensing therapeutic goods or any material likely to be used as evidence of the commission of an offense. The ban on removing materials will typically last up to eight weeks, although extensions up to around 12 weeks will be possible with the approval of other bodies in Pakistan. The text also covers the payment of fees.
Officials uploaded the text days after releasing draft therapeutic good advertising rules for consultation. The draft contains provisions that are like the existing drug advertising rules but has a broader scope that covers all therapeutic goods. DRAP is accepting feedback on the two drafts for 14 days.
DRAP Notice, More
India to update New Drugs and Clinical Trials Rules with details of non-clinical test methods
The Indian government has proposed changes to the New Drugs and Clinical Trials Rules, 2019. Officials plan to update the legislation with additional information about non-clinical testing methods.
Currently, the legislation states that the “requirements of non-clinical studies have been specified in the Second Schedule.” The revised document will retain that statement but also feature a new section about specific types of testing methods for assessing the safety and efficacy of new drugs.
The update lists cell-based assays, organ chips and micro physiological systems, sophisticated computer modeling, other human biology-based test methods and animal studies as non-clinical testing methods that new drug developers may deploy. The draft is open for comment for 15 days.
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