Asia Regulatory Roundup: China’s CDE Limits Face-to-Face Interactions to Curb Spread of Coronavirus

RoundupsRoundups | 04 February 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China’s CDE Limits Face-to-Face Interactions to Curb Spread of Coronavirus
China’s Center for Drug Evaluation (CDE) has taken steps to limit face-to-face interactions between its staff and people at the companies it regulates. CDE initiated the changes in response to the control measures implemented by the Chinese government to curb the spread of the coronavirus outbreak.
In a bid to stop the virus spreading out from the city of Wuhan, Chinese government officials have put in place measures that restrict the movement of people. CDE responded to those measures on Monday with a set of changes specific to its operation. The changes eliminate several forums for face-to-face interaction and replace them with remote communication.
As of 3 February, CDE will make greater use of its capacity to receive information from companies electronically. CDE has also suspended the in-person delivery of documents, choosing instead to only receive materials by mail.
The changes were implemented alongside a new approach to consultations between regulators and the companies they oversee. CDE has suspended on-site, in-person consultations and extended the hours during which it will conduct meetings via telephone to compensate for the restrictions. Applicants can also send CDE questions online and receive a response within 15 working days.
While the changes may cause some disruption for applicants, CDE wants to ensure developers of products that may help control the coronavirus outbreak are insulated from any upheaval. As such, CDE has said developers of coronavirus products can contact the center at any time.
CDE Notice (Chinese)
Philippine FDA Posts Guidance on Classifying Drug Production Deficiencies
The Philippine Food and Drug Administration (FDA) has updated its guidelines on the classification of deficiencies identified by inspectors of manufacturing facilities. The changes affect the handling of hard-to-classify deficiencies and manufacturer responses to the discovery of critical failings.
FDA published guidelines on the classification of good manufacturing practice (GMP) deficiencies early last year. The guidelines defined “critical”, “major” and “other” deficiencies and described the steps manufacturers need to take when an inspector finds the most severe type of failing. However, the document lacked details set out in a Pharmaceutical Inspection Co-operation Scheme (PIC/S) text on the risk-based classification of GMP deficiencies that was issued in January 2019.
The latest FDA update revises its original guidelines in light of the PIC/S. One of the biggest changes is the addition of a section that describes “cases where a deficiency may not be clearly classified.” In such situations, the FDA guidelines call for inspectors to follow PIC/S guidance on determining GMP deficiencies, starting with the initial classification steps before evaluating factors that could increase or reduce the risk.
FDA has also tweaked its position on what happens when an inspector identifies a critical failing. The new guidelines give companies three calendar days to justify the continued production, importation or distribution of the product subject to the critical deficiency. In another change, FDA said actions to address deficiencies must happen “not later than the timeline as defined in the relevant system and procedure of the inspection service of FDA.”
FDA Guidelines
Merck’s HPV Vaccines Pass TGA Laboratories’ Quality Control Tests
Merck’s Gardasil 9 Human Papillomavirus 9-valent Vaccine has passed quality tests conducted by TGA Laboratories. The testing arm of Australia’s Therapeutic Goods Administration (TGA) analyzed Merck samples representing 850,000 doses of Gardasil 9 without finding any quality problems.
Against a backdrop of vaccine hesitancy in parts of Australia, TGA Laboratories has tested the quality of prophylactics sold in the country, generating evidence that shots against measles and now human papillomavirus (HPV) meet the required standards. The latest tests focused on Merck’s HPV vaccine Gardasil 9.
TGA Laboratories found all the samples to be in compliance with the approved specifications and the European Pharmacopoeia HPV vaccine monograph. TGA said the testing “indicates that the manufacturing control strategy in place is working to deliver a consistent product of the expected level of quality.”
Australia has provided free HPV vaccines to girls aged 12 to 13 since 2007. In 2013, Australia extended the program to boys. The results of the program so far led the International Papillomavirus Society to predict Australia could eliminate cervical cancer as a public health issue by 2035. To do so, Australia will need to achieve immunization rates high enough to provide herd immunity.
TGA Notice
CDSCO Commits to 15-Day Turnaround for Certain Post-Approval Changes
India’s Central Drugs Standard Control Organization (CDSCO) has made changes to streamline the processing of post-approval changes to bioavailability and bioequivalence (BA/BE) studies. Following the changes, CDSCO will process post-approval changes within 15 days of receiving the request.
The BA/BE rules in India require sponsors to contact CDSCO if they want to make amendments such as a change to the study design or reduction in the number of participants. Prior written approval is needed to make major changes, whereas sponsors can simply notify the central licensing authority within 30 days of minor tweaks to their studies.
CDSCO has moved to ensure those requirements do not significantly hold up BA/BE clinical trials by committing to process requests within 15 days. The New Drugs and Clinical Trials Rules, 2019 do not commit CDSCO to a deadline for processing requests for post-approval changes.
CDSCO Notice
India Relaxes Rules on Adding Labels to Imported Medicines
CDSCO has made changes intended to reduce the regulatory burden on organizations that import medicines into India. The changes will free companies from the need to seek permission each time they want to add certain labels to the products they import.
Under the new rules, importers can seek a single “comprehensive permission” to overprint, sticker or stamp medicines they bring into the country. The old process required importers to make separate filings for each drug. CDSCO thinks the change will “further simplify the procedure” and “reduce the transaction time.”
The single permission will permit importers to apply stickers indicating that a product is not to be sold, either because it is for a hospital, institution or government, is a physician's sample or is for use in a clinical trial or managed access program.
Importers that want to apply such stickers need to comply with certain requirements, even after the change to the permission process. The new label must be added at the licensed manufacturing site and not conceal the information originally affixed to the imported medicine.
CDSCO Notice
Other News:
CDSCO has tasked its public relation office with responding to requests and grievances on the day it receives them. The office provides stakeholders with the chance to communicate issues in person. Under the new process, staff at the office will liaise with the division relevant to the issue and give a response to the stakeholder on the day of their visit. CDSCO also extended the scope of the office to cover veterinary medicines. Representatives of the veterinary division will be at the office one day a week. CDSCO Notice, More
The Indian government has tweaked its rules on the importation of oxytocin, a hormone misused by the dairy industry. India banned oxytocin to stop farmers from administering the drug to increase lactation. However, the government has now changed the law to permit the importation of oxytocin for testing and analysis. Gazette Notification


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