Asia-Pacific Roundup: Philippine FDA seeks feedback on clinical trial inspection deficiencies
The Philippine Food and Drug Administration (FDA) is running a consultation into draft guidelines on the classification of deficiencies observed during inspections of clinical trials, just weeks after the agency sought feedback on the classification of drug distribution deficiencies.The draft guidelines establish a uniform understanding and implementation of the classification of deficiencies seen in inspections of different phases of clinical trials for investigational products. FDA’s consultation offers companies a chance to comment on whether the agency will achieve those goals.
The attempt to establish a uniform understanding of clinical trial deficiencies centers on three definitions provided in the draft. FDA is proposing to define critical deficiency as “practices or processes that have been observed to adversely affect the rights, safety and/or well-being of the trial subjects, or the quality and integrity of data.” Serious violations of laws and guidelines can also be classed as critical deficiencies.
Under FDA’s proposed definition, inspectors will class clinical trial failings as major deficiencies if they “could potentially adversely affect” study subjects or data quality and integrity. Observations that “could represent” a violation of laws and guidelines also fall under the major deficiency definition. The minor deficiency classification is reserved for observations that are not expected to have adverse effects.
FDA may require organizations with critical deficiencies to suspend or terminate the clinical trial, except for activities that support the safety and wellbeing of participants. The agency may also reject data from the final clinical trial report and impose regulatory actions, “including disapproval of clinical trial related applications, or, after notice and hearing, suspension, or revocation of the issued authorization.”
Organizations that receive deficiency notices, regardless of their severity, will need to send a corrective action and preventive action plan and objective evidence of compliance to FDA within 15 working days.
The draft applies to sponsors, clinical research organizations, investigators, research ethics committees, FDA inspectors and other stakeholders involved in clinical trial inspections. FDA is accepting feedback until 20 May.
Draft Guidelines
CDSCO asks exporters to apply for no objection certificates via zonal offices
India’s Central Drugs Standard Control Organization (CDSCO) has asked exporters of unapproved, banned, and new drugs to “file fresh applications” for no objection certificates (NOCs).
In 2018, Indian officials tasked state licensing authorities with issuing NOCs to exporters of the products. That system will end this month. Starting 15 May, exporters will need to apply online to zonal offices to obtain NOCs. The head of each CDSCO zonal office will grant NOCs once the power to issue the certificates is taken away from state licensing authorities.
As part of the changes, CDSCO is asking state drug controllers to hand all NOCs issued between when they gained the powers in 2018 and ceded them in May 2024 to the appropriate zonal offices of CDSCO.
A representative of the Indian government told CDSCO about the changes in 2023. The official said the change was adopted after the Ministry of Health and Family Welfare examined the matter but provided no reasoning for the rethink. The letter specified filings should be “only on online mode to a point of contact at CDSCO headquarters” and handled through the agency’s zonal offices.
CDSCO Notice
DRAP finds ethylene glycol in drug products, triggering 3 recalls in Pakistan
The Drug Regulatory Authority of Pakistan (DRAP) has found unacceptable levels of ethylene glycol (EG) in three drug products sold by Biolabs.
DRAP issued one recall notice after the central drug laboratory in Karachi, Pakistan found the level of EG in a batch of Artecid injections exceeded the accepted limit. The product contains the non-steroidal anti-inflammatory drug diclofenac.
One day later, DRAP published a second notice about the levels of EG in batches of Mebzole suspension and Bioris oral solution. Mebzole is used to treat parasitic worm infestations. Bioris contains an atypical antipsychotic used to treat schizophrenia and bipolar disorder.
All three products are made by Biolabs. The Pakistan-based manufacturer triggered another DRAP alert earlier this year when it submitted a sample of propylene glycol for testing. A government lab found the sample contained unacceptable levels of EG and diethylene glycol. DRAP asked Biolabs to recall “any finished products that were manufactured using the same lot of propylene glycol.”
After Artecid, Mebzole and Bioris tested positive for unacceptable levels of EG, the agency asked Biolabs to immediately recall the defective batches from the market. DRAP also told pharmacists and chemists to immediately check their stocks and stop supplying the affected batches.
Artecid Notice, Mebzole Notice
PMDA uploads video about regulating software as a medical device in Japan
The Pharmaceutical and Medical Devices Agency (PMDA) has added a video about regulating software as a medical device (SaMD) in Japan to its training materials.
In the five-minute, English-language video, PMDA provides global and Japanese definitions of medical devices, plus the International Medical Device Regulators Forum’s definition of SaMD. PMDA also covers the risk-based classification of medical devices and SaMD in Japan.
“Generally, SaMD has less risk than traditional MD because SaMD is noninvasive. Therefore, the risk classification of software as a medical device is different from that of medical devices other than SaMD,” PMDA said. “Software products equivalent to a Class I medical device have no risk and are not regulated by the [Pharmaceutical and Medical Device Act in Japan].”
PMDA goes on to describe how to review SaMD. In principle the process is the same as for non-software products. PMDA assesses the purpose of development and intended use before evaluating the safety and effectiveness of the product based on nonclinical and clinical data.
The agency is asking companies to specific input and output data, the algorithm and user environment in applications. Applicants should identify risks in SaMD and confirm requirements for software products’ lifecycle processes.
PMDA Video
Philippine FDA tells companies to file financial relationship disclosure reports
The Philippine FDA has told manufacturers and other licensed organizations to submit reports disclosing their financial relationships with healthcare providers and healthcare professionals.
A Philippine law approved in 2019 requires all FDA-licensed manufacturers, traders, repackers, importers, and wholesalers of drugs, medical devices, and biological products to collect and track their financial relationships with healthcare providers and healthcare professionals. Companies need to report the data to the Department of Health, through the FDA.
FDA published guidance on how to submit the information using the online disclosure reporting system in 2021. FDA said the online system enables stakeholders to conveniently submit all financial relationship disclosure reports. Last week, FDA reminded the industry to submit disclosure reports for 2023 through the system.
FDA Notice
Other News:
Australia’s Therapeutic Goods Administration (TGA) has shared details of Haleon Australia’s product defect correction for 14 batches of an oral liquid paracetamol formulation. The products contain a syringe for administering the oral formulation to children aged one month to one year. However, the affected syringes may be stiff and hard to use, creating a choking risk. Affected customers should dispose of the syringe and use an alternative. TGA Notice
The Indian Pharmacopoeia Commission (IPC) has signed a memorandum of understanding with the Institute of Microbial Technology, Chandigarh. The agreement positions the organizations to collaborate on the development of new technologies. IPC Notice
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