Regulatory Focus™ > News Articles > 2021 > 10 > Asia-Pacific Roundup: China’s NMPA applies for pre-accession to PIC/S

Asia-Pacific Roundup: China’s NMPA applies for pre-accession to PIC/S

Posted 05 October 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: China’s NMPA applies for pre-accession to PIC/S

China’s National Medical Products Administration (NMPA) has applied for “pre-accession” to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The voluntary step is intended to identify gaps between PIC/S membership requirements and the system used by the regulatory agency.
 
PIC/S held a bilateral meeting with NMPA late in 2019 to discuss issues raised by the Chinese drug regulatory agency in relation to a possible future application or pre-application. Almost two years later, NMPA has formally begun the process of assessing if it meets all the requirements for joining the international good manufacturing practice cooperative agreement.
 
Pre-accession takes up to two years. In that time, PIC/S will perform a gap analysis to identify areas of divergence from its requirements. The first action is to nominate a rapporteur and one or more co-rapporteurs who will manage the pre-accession process. Based on the gap analysis, the PIC/S committee will decide on the next steps such as inviting the authority to apply for membership.
 
NMPA’s interest in PIC/S could continue the expansion of the scheme. Over the past year, Brazil has joined PIC/S and Russia and Jordan have applied to take part. India, which has already engaged in talks with PIC/S in recent years, is reportedly preparing for assessment by the scheme. 
 
PIC/S Notice
 
India’s NPPA hits back against claim it aids pharma pricing malpractices
 
India’s National Pharmaceutical Pricing Authority (NPPA) has strongly condemned allegations that it actively connives with companies engaging in corrupt practices. NPPA issued the rebuttal in response to comments made by the head of a regional pharmaceutical distributors association.
 
The allegations were reported in The Daily Excelsior. According to the newspaper, the head of the Jammu Pharmaceutical Distributors Association said pharma companies are selling their medicines at different prices to different sectors, such as private hospitals, doctors, clinics and direct distributors, despite the products having a single maximum retail price (MRP). The newspaper called the alleged activities “shocking malpractices.”
 
NPPA is empowered to set the ceiling prices for medicines and punish companies that overcharge. However, the newspaper report said the practices are happening with the “active connivance” of the Indian price watchdog. The report accuses NPPA of “adopting unethical practice of looting the poor patients.”
 
The article drew a response from NPPA, which said it “strongly condemns such false statements regarding its connivance in any of the malpractices adopted by the pharmaceutical companies.” The price watchdog added that it lacks the regulatory authority to do anything about companies that set different prices below the MRP to different sectors.
 
NPPA Statement
 
Australia to lift ban on at-home COVID-19 tests next month
 
Australia is set to allow the sale of rapid antigen COVID-19 self-tests for home use from 1 November onward. The Therapeutic Goods Administration (TGA) responded by starting to accept applications from companies that want to provide tests to the Australian market.
 
TGA has laid the groundwork for the change in the legal status of rapid antigen tests in recent weeks by publishing guidance and seeking expressions of interest from developers of the diagnostics. The work has enabled TGA to respond quickly to the proposed lifting of the ban. The review of data from companies that registered their interest with TGA is already underway.
 
Tests will need to get TGA approval and be included in the Australian Register of Therapeutic Goods to come to market. TGA wants test developers to provide instructions that lay people understand and support such as online videos, as well as showing how their kits perform against variants.
 
To support applicants, TGA updated its guidance on performance requirements and risk mitigation strategies for COVID-19 rapid antigen self-tests. The revised guidance includes an update to analytical
requirements and the additional conditions that may be applied.
 
TGA Notice
 
Review finds MDMA, psilocybin ‘may show promise’ ahead of TGA scheduling decision
 
MDMA and psilocybin “may show promise in highly selected populations” but must be “administered in closely clinically supervised settings and with intensive professional support,” according to experts commissioned by TGA to review the evidence.
 
TGA ordered the independent review to inform a decision on whether to down-schedule the drugs. The agency, after reviewing more than 1,000 responses to a consultation, proposed maintaining the current rules in February, only to delay its final decision to gain the time to seek further advice. The publication of the independent review marks the end of the gathering of information.
 
The Advisory Committee of Medicines Scheduling is set to meet early next month to discuss the report and whether to down-schedule the two molecules from prohibited to controlled drug status.
 
TGA’s prohibited schedule includes drugs “that have a high propensity for dependency and abuse” but can still be made available for research with the approval of Australian health authorities. A controlled drug is a medicinal substance intended for human therapeutic use that is still subject to restrictions on its availability.
 
TGA Notice, Independent Review
 
Philippine FDA seeks feedback on classification of drug distribution deficiencies
 
The Philippine Food and Drug Administration (FDA) is seeking feedback on the classification of deficiencies identified during inspections of drug distributors and retail outlets.
 
Citing Philippine law, FDA framed the draft guidance as helping to fulfill its goal of giving consistent responses to inspections and providing uniform understanding of the classification system. FDA is proposing three ranks for deficiencies identified during inspections of good distribution and storage practices (GDSPs).
 
The agency will class departures from GDSPs that lead to “a significant risk to the patient or public health” and serious situations that may result in a regulatory action as critical deficiencies. Establishments that engage in “fraud, misrepresentation or falsification of pharmaceutical products or data documents” will also receive critical deficiencies.
 
Major deficiencies, the next rank down from critical, cover major deviations from GDSPs that have a “direct effect” on the quality or efficacy of pharmaceutical products. FDA may also issue major deficiencies to establishments that rack up several deficiencies that fall into the “other” category. The other category is a catch-all classification for GDSP deviations that are neither critical nor major.
 
FDA is accepting feedback on the draft until 8 October.
 
Draft Guidance
 
TGA proposes recognizing AstraZeneca and Sinovac vaccines to enable international travel
 
TGA has proposed classifying COVID-19 jabs from AstraZeneca and Sinovac as “recognized vaccines,” enabling travelers who received them to meet Australian border requirements despite the products not being authorized in the country.
 
With the vaccination rate in Australia edging toward the government’s target for reopening, TGA has assessed the protection offered by Sinovac’s Coronavac and AstraZeneca and Serum Institute of India’s Covishield to inform the status of travelers vaccinated with the products. The vaccines are used widely in parts of the world but are yet to be authorized in Australia.
 
TGA concluded the products offer enough protection against infection and serious illness to be classed as “recognized vaccines.” The decision clears a barrier to travel from countries with ties to Australia including the UK, where Covishield was widely used in people aged 40 years and older.
 
While proposing to recognize Coronavac and Covishield, TGA ruled there is currently insufficient evidence to reach a conclusion about the protection offered by Sinopharm’s BIBP-CorV, Bharat Biotech’s Covaxin, Gamaleya Institute’s Sputnik V and CanSino’s Convidecia. TGA may recognize the vaccines in the coming weeks or months “as more data becomes available.”
 
TGA Notice

 

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