Regulatory Focus™ > News Articles > 2021 > 1 > Asia-Pacific Roundup: Japan’s PMDA shares process for certain remote inspections

Asia-Pacific Roundup: Japan’s PMDA shares process for certain remote inspections

Posted 26 January 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: Japan’s PMDA shares process for certain remote inspections

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published its procedure for conducting remote compliance inspections related to drugs and regenerative medical products.
 
PMDA set out its approach to remote inspections late last year, before going on to post an English translation of the document last week. The document details the different steps of the remote inspection process and what applicants can do to prepare.
 
PMDA will inform an applicant of its plans to conduct a remote inspection and share a schedule. The applicant will need to present documentation for PMDA staff review in a pre-inspection step. The inspectors will tell the applicant of any concerns identified during the pre-inspection before the main assessment. PMDA will use the main inspection to interview the applicant via video conference and view documents not shared ahead of time. Further interactions may happen after the inspection.
 
To help applicants prepare, PMDA has created points to consider regarding documentation and the cloud and video conferencing systems used to enable remote inspections. PMDA is asking applicants to establish procedures for scanning paper documents that result in clear, complete and consistent digital versions of the physical files. Applicants may also need to present original paper documents.
 
Regarding the cloud and video conferencing system, PMDA said the applicant needs to contract with a service provider to access the technology, cover the costs of its use and ensure its security. If the system is compromised, the onus is on the applicant to promptly tell PMDA of the security problem and take appropriate actions. The document also covers points specific to cloud systems, for example by stating that in principle it is sufficient to grant inspectors read-only access to documents.
 
The procedure came into force upon the publication of the Japanese version late last year. PMDA is using the document to guide its approach to good clinical practice assessments of drugs and regenerative medicines submitted for approval, as well as to good postmarketing study practice assessments of products that are already on the market.
 
PMDA Procedure
 
Donated COVID vaccines require regulatory authorization, Philippine FDA says
 
The Philippine Food and Drug Administration (FDA) has clarified that donated COVID-19 vaccines need emergency use authorization (EUA). The clarification comes shortly after China pledged to donate 500,000 doses to the Philippines.
 
Philippine officials have agreed to buy 25 million doses of CoronaVAc, the COVID-19 vaccine developed by China’s Sinovac, and secured supplies to other prophylactics. China is set to supplement the existing supplies by giving the Philippines 500,000 doses of an as-yet-unidentified COVID-19 vaccine.
 
The agency said the Philippine Department of Health (DOH) will facilitate the processing of all donations and evaluate factors such as the shelf life of the products and the reliability of the source.
 
The Chinese vaccines may face an additional step. FDA has granted EUA to Comirnaty (Pfizer/BioNTech) and received applications from AstraZeneca and Gamaleya, the developer of Russia’s Sputnik V. If China donates a locally developed vaccine that is yet to be cleared for use in the Philippines, DOH will need to apply for EUA. Distribution can only occur after the EUA is granted and is tied to certain conditions.
 
“Let it be stressed that the approval of the donated product does not mean free use thereof. FDA’s authorization is limited to the donated lot and carries conditions for use depending on the nature of the donated product. DOH, as the donee, is mandated by the FDA to assume full responsibility on the use of the donated product,” FDA wrote.
 
FDA Notice
 
TGA seeks volunteers for ongoing GCP inspection program after finishing pilot
 
Australia’s Therapeutic Goods Administration (TGA) is seeking volunteers for its good clinical practice (GCP) inspection program. TGA is particularly keen for sites involved in clinical trials of COVID-19 vaccines to participate in the initiative.
 
In 2019, TGA began a pilot program to assess the feasibility of running a domestic GCP inspection program capable of managing risk and improving the global reputation of Australian clinical trials. The final phase of the pilot was disrupted by the COVID-19 pandemic last year but by then TGA had seen enough to persuade it to keep pursuing the idea.
 
Now, TGA, having received government endorsement for an ongoing GCP initiative, is seeking volunteers for the next phase of the inspection program. TGA is running the next phase to refine its inspection processes and approach. The agency said “investigator sites involved in clinical trials of SARS-CoV-2 vaccine candidates are particularly encouraged to consider volunteering.”
 
As TGA disclosed late last year, the program will now incorporate remote inspection processes. TGA added a few further details in its request for volunteers, stating that inspections will take place over three days and may be performed remotely. There is no charge for participating in the program. 
 
TGA Notice
 
Malaysia’s MDA clarifies rules on importing and supplying COVID-19 test kits
 
Malaysia’s Medical Device Authority (MDA) has set out the rules on importing and supplying tests of COVID-19 during the pandemic. The tests are exempted from the normal registration rules under a 2016 order but still subject to certain requirements.
 
Anyone planning to import or supply COVID-19 test kits needs to notify MDA to obtain permission to make the products available in Malaysia. A committee set up by MDA will evaluate the test kits covered by the application and make a recommendation about whether they should be cleared for distribution in the country.
 
Successful applicants can provide their tests to medical professionals but not to the public. MDA used the notice to remind successful applicants to only ship tests to sites listed in their acceptance letters.
 
MDA Notice (Malaysian)
 
CDSCO committee asks Eli Lilly to study glucagon nasal powder in Indian patients
 
India’s endocrinology and metabolism Subject Expert Committee (SEC) has told Eli Lilly to conduct a local clinical trial of its glucagon nasal powder.
 
Lilly went to SEC to ask officials to waive the need to conduct a clinical trial in India before bringing its treatment for severe hypoglycemia in diabetics to market. India permits the waiving of local trials under the New Drugs and Clinical Trials Rules, 2019, enabling companies to access the Indian market using data generated overseas, but only in certain circumstances.
 
SEC heard Lilly make its case in a presentation last week. The committee knocked back the request. “After detailed deliberation the committee recommended that the firm should conduct clinical trial in Indian population and accordingly protocol should be submitted for review by the committee,” SEC wrote in the summary of its recommendations.
 
SEC Recommendations
 
Other News:
 
The Drug Regulatory Authority of Pakistan (DRAP) has given developers of COVID-19 vaccines until 6 June to seek emergency use authorization (EUA) of their candidates. DRAP is asking authorization holders to submit data from six-month real-time stability studies within one year. The policy update comes shortly after DRAP granted EUA to COVID-19 vaccines from AstraZeneca and SinoPharm-subsidiary China National Pharmaceutical Group. DRAP Notice
 
The Philippine FDA has issued a public health warning against the use of uncertified COVID-19 test kits intended for self-administration. FDA Notice

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe