Asia-Pacific Roundup: Indian Pharmacopoeia seeks feedback on disinfecting drug production plants

The Indian Pharmacopoeia Commission (IPC) has released for consultation draft guidance on the use of disinfectants and antiseptics in drug manufacturing facilities. The document is an updated version of the drafts for consultation IPC published in March and July.

IPC has retained the core content of the document throughout the rounds of feedback and revisions because they believe that “a sound cleaning and sanitization program is needed for controlled environments used in the manufacture of pharmaceutical articles to prevent the microbial contamination of these articles.” Disinfectants and antiseptics can help meet that need; however, such use can create additional issues.

The draft general information chapter delineates those issues. IPC would like manufacturers that use disinfectants to take care to stop the cleaning agents from contaminating the drug product, reflecting “the inherent toxicity of the disinfectants,” IPC wrote.

The draft guidance also addresses the use of antiseptics to decontaminate human skin and exposed tissue, chemical sterilants to decontaminate surfaces in manufacturing, and sterility testing areas and UV irradiation as a surface sanitizer. The text discusses choosing chemical disinfectants, antiseptics and sterilants; showing bactericidal, fungicidal and sporicidal efficacy; using the agents; and regulatory and safety considerations.

Most of the document is unchanged from the version released for first consultation in March. The updates include the addition of a line about which parts of a good manufacturing practice (GMP) site should be cleaned.

“All GMP areas should be subject to cleaning; disinfection must also be performed in areas where it is necessary to control environmental bioburden, for example: where starting and primary packaging materials, intermediate or bulk products are exposed to the environment, and in sterile production facilities,” IPC wrote.

The third version of the draft also features an update to IPC’s position on sporicidal agents. Originally, IPC said, “the daily application of sporicidal agents is not generally favored because of their tendency to corrode equipment and because of the potential safety issues with chronic operator exposure.” The latest version retains those concerns but notes that the agency can be used in “isolator systems where an automated sporicidal application is required/recommended.”

That change is one of several revisions to a section of the document that addresses disinfectants used in cleaning and sanitization programs. IPC said, “disinfectants applied on potential product contact surfaces are typically removed with 70% alcohol wipes” in its first draft, adding that “the removal of residual disinfectants should be monitored for effectiveness as a precaution against the possibility of product contamination.”

Officials have removed those statements. The latest draft states, “the requirement to remove disinfectant and cleaning agent residues from surfaces should be considered, where appropriate, as a precaution against: inactivation any disinfectant subsequently applied; damage to facility surfaces; interference in recovery of microorganisms during surface monitoring and potential product contamination.”

IPC is accepting feedback on the draft until 8 December.

Draft Proposal

Hong Kong extending ‘1+’ scheme to all new drugs, taking other steps to accelerate approvals

Hong Kong is set to extend its “1+” authorization mechanism to all new drugs as part of a broader push to accelerate approvals and reform the regulation of medicines and medical devices.

Previously, Hong Kong required products to have received approval from two separate regulatory authorities to come to market in the special administrative region. The 1+ mechanism allowed products to come to market based on one overseas approval. The chief executive of Hong Kong proposed the mechanism last year but initially restricted its use to life-threatening or severely debilitating diseases

Now, the chief executive has called for the extension of the mechanism to all new drugs. Hong Kong’s Department of Health will make the change on 1 November. The action builds on the experience gained during the limited use of the mechanism over the past year, in which time around 80 companies made 260 inquiries about the scheme. Hong Kong has approved five new drugs under the mechanism.

Starting in the first quarter of 2025, officials plan to offer a consultation service for new drug applications under the “1+” mechanism. The new service is intended to “enhance the efficiency in processing relevant applications.”

The mechanism will provide pharma companies with a faster route to market while officials work to set up the Hong Kong Centre for Medical Products Regulation. The chief executive wants officials to create a timetable for establishing the regulatory agency and charting a roadmap towards “primary evaluation” in the first half of 2025.

The timetable is one of several regulatory projects with deadlines in 2025. Working with the Shenzhen Government, Hong Kong plans to establish the GBA Clinical Trial Collaboration Platform next year. The platform will “provide services on consultation, matching, referral, etc. to medical research organizations conducting clinical trials in Hong Kong and the [Greater Bay Area],” the chief executive said.

Press Release, Policy Addr]ess

Five years after switching to CTD, DRAP sets deadline for phasing out old application form

The Drug Regulatory Authority of Pakistan (DRAP) has told companies to stop using old forms and switch to the common technical document (CTD) by the end of 2024.

DRAP implemented Form-5F in March 2019, moving Pakistan to the CTD and marking the deadline for the use of Form-5 and Form-5A. However, some companies continued to make submissions using the old forms. Pakistan’s Registration Board discussed the situation at a meeting in August, noting that the old forms are “creating [a] hurdle in reducing the pendency of current registration applications.”

“Replies of such applications submitted after said date shall not be entertained, and all such applications shall be considered as disposed of, and the applicant firm may submit [a] fresh application on Form-5F, which will be considered on its turn in the queue of Form 5F,” DRAP said.

DRAP shared details of the deadline alongside an update on submitting stability data using Form-5 and Form-5D. The regulator will endorse applications submitted until 30 June 2023. Applicants who used the old forms after that date need to reapply using Form-5F.

DRAP Notice, More

Indonesia’s BPOM discusses plans to accelerate the registration of generic medicines

The Indonesian Food and Drug Authority (BPOM) has published details of its work with the pharma industry to accelerate the registration of generic medicines.

In a summary of a recent meeting about its activities, BPOM quoted industry statistics about the number of expired distribution permits and data on the predominance of generic drugs in the national formulary. Seeking to ensure the supply of generic medicines, BPOM has called on the pharma industry to meet its quality standards and thereby help accelerate regulatory processes.

BPOM has split the work on the distribution permits up into three monthly stages that will run from October through to the end of the year. The regulator plans to address more than 900 permits across the three stages.

BPOM Notice (Indonesian)

Asia-Pacific Roundup: Indian Pharmacopoeia seeks feedback on disinfecting drug production plants

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