Asia-Pacific Roundup: TGA gives sponsors two months to complete pharmacovigilance risk assessment survey

RoundupsRoundups | 18 October 2022 |  By 

Australia’s Therapeutic Goods Administration (TGA) has given medicines sponsors until 18 December to complete its Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey. Sponsors that fail to answer the questions by the deadline will be assigned the highest survey risk score.
 
After piloting a pharmacovigilance inspection program in its 2015 to 2016 financial year, TGA began requiring all sponsors to complete a survey to inform its risk-based approach to scheduling inspections. The approach means TGA is less likely to regularly inspect pharmacovigilance systems with lower-risk products or good compliance history, although it also runs random and for cause inspections.
 
The current survey features 24 questions that cover factors related to the products, sponsor, inspection history and pharmacovigilance system that TGA considers when assigning a risk score. On the product side, TGA wants to know the number and types of medicines that sponsors have in the Australian Register of Therapeutic Goods (ARTG), plus details such as the proportion of products that are included in Schedule 4 or 8 of the Poison Standard or are subject to licensing deals with other companies.
 
TGA’s pharmacovigilance system questions address the use of third parties to perform certain activities. The agency wants sponsors to tick off the pharmacovigilance activities they have outsourced in the past two years, such as adverse event case collection, ongoing safety evaluation and the submission of periodic safety update reports. Other questions address whether the third party has been inspected and whether the sponsor has made, or is planning to make, changes to its drug safety database.
 
The survey also addresses compliance with pharmacovigilance reporting, for example by asking what proportion of serious adverse reaction reports were submitted to TGA within 15 calendar days. Across the final two sections of the survey, TGA asks questions about safety related variations, such as whether the sponsor has changed the labels of their products in the past two years, and prior inspections.
 
TGA wants to know if a comparable overseas regulator, such as the agencies in the US and European Union, has inspected the sponsor’s pharmacovigilance system in the past five years and whether the respondent has previously been the subject of an Australian PVIP assessment.
 
In its 2020 to 2021 financial year, TGA conducted six PVIP inspections, down from eight the previous year. TGA found three critical deficiencies, 27 major deficiencies and 15 minor deficiencies during the inspections.
 
TGA Notice
 
Japan’s PMDA adapts guidance on product identification codes to regenerative medicines
 
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published guidance on using codes on packaging to identify regenerative medical products. The guidance is the sibling of a document that PMDA made to address how to label containers with codes to identify prescription drugs.
 
Both documents carry the same date, indicating that PMDA released the Japanese-language versions at the same time in response to a ministerial order about the amendment of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. However, PMDA posted the English-language version of the prescription drug guidelines before the regenerative medicine text.
 
The guidelines follow the same format, with PMDA providing tables that state the information that is mandatory and optional for each layer of packaging, but the products covered by the rules are different. In the latest translation, PMDA differentiates between designated regenerative medical products and all other types of regenerative medical products. The inclusion of the expiration date and manufacturing code on the unit of individual packaging is only mandatory for designated regenerative medical products.
 
PMDA’s regenerative medical products guidance differs from the prescription drugs document in other ways, too. For example, the section on the barcode symbol system is simplified, with PMDA only stating that “an appropriate barcode among GS1 DataBar Limited/Stacked, their composite symbol (CC-A), GS1-128 symbol, and GS1 DataMatrix shall be used.”
 
PMDA Guidance
 
Pakistan’s DRAP tells companies to start stability studies by the end of 2022
 
The Drug Regulatory Authority of Pakistan (DRAP) has asked certain sponsors to start product development and stability studies in relation to their submitted applications by the end of the year.
 
DRAP’s request applies to applications received on Form 5/5D that require the submission of stability data for further processing. At a meeting earlier this year, Pakistan’s Registration Board considered the submissions and reached a conclusion about the next steps. DRAP communicated the board’s plan in a statement on Monday.
 
“The firms shall initiate the product development and stability studies of submitted applications and intimate to Pharmaceutical Evaluation Cell regarding procurement of raw material, initiation of product development and initiation of stability studies by 31st December 2022. For all those applications for which Pharmaceutical Evaluation Cell will not receive any intimation regarding initiation of product development and stability studies, will be placed before the board for decision,” the board said.
 
DRAP linked to a list of applications affected by the notification. The list of “applications for registration of drugs on Form 5 / Form 5D awaiting for submission of stability data” features 2,010 entries. The submission dates from the entries range from 2010 to 2019. Sanofi-aventis Pakistan Limited has one entry on the list, namely a Tritace protect tablet with a submission date in 2012.
 
DRAP Notice
 
India’s CDSCO assigns oncology medical devices to risk categories under MDR, 2017
 
India’s Central Drugs Standard Control Organization (CDSCO) has assigned 48 oncology medical devices to risk categories. The assignments are part of the implementation of the Medical Devices Rules, 2017.
 
CDSCO has assigned two medical devices to its highest risk classification, category D. The devices are an alternating electric field antimitotic cancer treatment system and a coronary artery brachytherapy system applicator. The rest of the devices are spread across the other three categories, with more than half of the items falling in class C. The class C devices include cryosurgical sets and capsular tension rings.
 
The regulatory agency has also published a list of risk classifications for 95 dental medical devices. Most of the dental devices are lower risk, leading CDSCO to assign them to class A and class B, but there are some class C products.
 
CDSCO Notice, More
 
Other news:
 
TGA has fined an individual AU$5,328 ($3,366) for allegedly running an advert that implied a listed complementary medicine was recommended or approved by or on behalf of the Australian government. The individual is also accused of referencing cancer, a prohibited representation, in the advert. TGA responded by issuing two infringement notices to the individual. TGA Notice
 
PMDA has published an English-language translation of a document about its approval of the CureApp HT digital therapeutic app for the treatment of hypertension. The Japanese agency approved the product without designation as a medical device after reviewing data from a clinical trial that linked the app to a significant change in mean 24-hour ambulatory systolic blood pressure. PMDA Report 
 
DRAP has published the names of the people who will sit on its clinical studies committee for the next three years. The committee features five academics, plus one representative each from the Pakistan Pharmaceutical Manufacturers Association and Pharma Bureau who will serve as observers. Two DRAP employees are also involved. DRAP Notice

 

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