Asia-Pacific Roundup: DRAP publishes guidance on trials, biosimilarity studies of drugs made in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) has published guidance on the requirement for clinical trials or biosimilarity studies to support the registration of locally manufactured biological medicines.

DRAP said its staff created the document to provide a better illustration of data requirements for clinical trials of locally manufactured biological drugs. The guidance applies to companies that intend to seek marketing authorization of such products. DRAP said the text could help those companies complete their filings for approval.

The guidance is split into two sections. Most of the document applies to products that use “imported bulk/concentrate/ready-to-fill/naked vials.” DRAP said companies seeking approval of such drugs must provide complete clinical trial or biosimilarity data “as submitted for approval either from regulatory body of country of origin or by any reference regulatory authority as adopted by Registration Board.”

For non-reference authorities, applicants need to send evidence that the submitted data aligns with the guidelines for evaluation of biotherapeutics in the country of export. Other requirements include the submission of a good manufacturing practice (GMP) certificate for the company that makes the vials and free sale and lot release certificates from the country of origin.

Another set of requirements applies to quality studies. DRAP expects companies to perform accelerated and real-time stability studies for the drug substance and run analytical studies to evaluate the protein content, check for particles and assess in vitro biological activity. Applicants should run all the tests locally.

The section on locally manufactured vials only features one point, in which DRAP sets out the need for applicants to submit complete clinical trial or biosimilarity data, depending on the type of product they are developing.

DRAP Guidance

Singapore’s HSA updates guidelines on software as a medical device risk classification

Singapore’s Health Sciences Authority (HSA) has updated guidelines on the risk classification of software as a medical device (SaMD) and the qualification of clinical decision support software (CDSS).

HSA listed several key updates to the first version of the guidelines, which it published in 2022. The agency has changed the title to make it easier to find in online searches and adopted the term SaMD, rather than “standalone medical mobile applications”, to improve alignment with international practices. Another change affects when HSA will not classify CDSS as a medical device.

“Software are not regulated as medical devices when the software is designed in a manner that their output or recommendations are solely based on established clinical guidelines,” HSA said. “Such software serves as a repository of medical information in digital format and do not generate new or modified clinical recommendations beyond what are established in the clinical guidelines.”

HSA provided examples of software that is not a medical device. Software that healthcare professionals use to analyze a patient’s symptoms and test results against accepted clinical guidelines to recommend specific diagnostic tests or therapy does not meet the device classification criteria. Similar thinking applies to software that is used to recommend the most appropriate surgical action.

The agency also updated its position on when SaMD products are classified as Class B. The revised text states SaMD will fall into Class B when they are used to analyze, measure or monitor a vital physiological process or anatomical structure images to support patient management.

HSA Notice

DRAP starts phased implementation of bioequivalence data requirements in Pakistan

DRAP has started the first part of a planned phased implementation of bioequivalence requirements in Pakistan.

Officials decided to implement bioequivalence study requirements last year as part of a push to meet a World Health Organization requirement for regulators to have certain procedures for registering generic drugs. The decision led DRAP to hold meetings with manufacturers and other stakeholders to formulate a roadmap for implementing the requirements.

DRAP recently began the first phase of the implementation process, making it mandatory for companies to submit bioequivalence studies for 23 drug substances and all tuberculosis and HIV medicines. The TB and HIV requirements apply to “both single ingredient as well as in combination requiring BE studies as per [biopharmaceutics classification system] criteria,” DRAP said.

The selection of products for the first phase of the implementation reflects risk-based criteria. DRAP has prioritized molecules that have low solubility and low permeability or a narrow therapeutic range. Drugs with low solubility that are part of a national program, such as Pakistan’s work on TB and HIV, are another area of focus.

DRAP Notice, Meeting Minutes

New Zealand’s Medsafe posts warning about scam ads after tracking uptick in fake info

New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) has posted a warning about ads that falsely use its credentials.

Medsafe has seen a rise in websites and social media posts that claim it has approved, recommended, sponsored or endorsed certain products or services. The agency has alerted the public that the ads are fake. Medsafe also flagged the unapproved use of its logo on websites and in social media posts. Other websites claiming to be Medsafe are fake, the agency said.

“We have requested removal of this fake information from the internet,” Medsafe said. “However, as these websites and social media platforms are usually based overseas, fake information often reappears.”

Medsafe has shared advice to help consumers and healthcare professionals spot fake information. The agency has no social media presence and does not advertise, recommend, sponsor or endorse any products or services promoted on the internet.

Medsafe Alert

India’s CDSCO orders ranitidine manufacturers to monitor levels of nitrosamine impurity

India’s Central Drugs Standard Control Organization (CDSCO) has told companies that make ranitidine to monitor levels of the impurity N-nitrosodimethylamine (NDMA).

Ranitidine, which is sold under brand names including Zantac, was withdrawn in markets, including the US, in 2020 in response to the discovery of NDMA, an impurity that may cause cancer. CDSCO formed an expert committee to look into the safety of ranitidine last year, leading to the presentation of a report to the Drugs Technical Advisory Board (DTAB) earlier this year.

DTAB recommended the formation of a larger committee to look into all aspects of the storage of the drug. The board also suggested that the Indian Council of Medical Research study the safety of the drug, considering the presence of NDMA.

Advice to manufacturers includes a call to monitor levels of the impurity in their ingredients and finished products. DTAB also asked companies to take risk-based measures such as reducing the shelf lives of their products. CDSCO recently asked its regional regulatory units to tell manufacturers to comply with the DTAB requests.

CDSCO Notice

Other News:

DRAP published the second edition of Pakistan’s health emergencies preparedness and risk management plan. The agency said it has added information on “where risk management is applied on a product life-cycle with respect to regulatory preparedness, with particular emphasis on pre-emergency preparedness and emergency response phase.” GMP inspection reliance is another new topic. DRAP Plan

The regulatory agencies of South Korea and Japan have published a joint statement about their cooperation. Japan’s Pharmaceuticals and Medical Devices Agency and Korea’s Ministry of Food and Drug Safety confirmed their continued commitment to regulatory cooperation on the 10th anniversary of the signing of a memorandum of understanding. Joint Statement

Asia-Pacific Roundup: DRAP publishes guidance on trials, biosimilarity studies of drugs made in Pakistan

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