Asia-Pacific Roundup: India updates pharmacovigilance guidance, extending event reporting deadline

Indian authorities have released version 2.0 of their pharmacovigilance guidance, enacting changes such as extending the deadline for reporting non-serious adverse events and revising record-keeping requirements.

The Indian Pharmacopoeia Commission and Central Drugs Standard Control Organization published the first version of the guidance in 2018. Later, an expert committee worked to revise the text, leading to the publication of a draft copy for consultation. Most of the final text is unchanged from the draft version, but the authorities have made some key revisions.

In the draft, Indian authorities proposed keeping an old requirement for marketing authorization holders (MAHs) to report non-serious adverse events within 30 calendar days of receiving information on the events. The final version extends the deadline to 90 calendar days.

The final version also features changes to a subsection on document and record control, which now says, “MAHs shall maintain a logbook/excel spreadsheet/electronic data management tools for recording primary information received for every adverse event reported.”

Indian authorities highlighted the changes to reporting timelines and record maintenance as two new things in the document. The list also includes updates to reflect the New Drugs and Clinical Trials Rules, 2019 and revised Schedule M of Drugs and Cosmetics Rules, 1945, the switch to the MedDRA dictionary for coding indications, and the removal of a Periodic Safety Update Report checklist.

Another change is the addition of subsections on inspection procedures, findings and follow-up, responding to inspection findings, regulatory actions, and inspector training. The draft contained subheadings for regulatory actions and training inspectors, but the details were missing. Adding the information fills gaps that could help companies navigate the pharmacovigilance inspection process.

“Inspection procedures depend on the nature (routine/targeted) of the inspection and the conditions of inspection request,” the guidance states. “All the necessary PV documents should be submitted to the inspectors during inspection. When necessary, the inspectors may also request other documents related to the inspection, including job descriptions of PV personnel, products, and company-related information, etc.”

Pharmacovigilance Guidance, More

Medtronic receives largest ever Australian fine for unlawful therapeutic good supply

The Federal Court of Australia has ordered Medtronic Australasia to pay AU$ 22 million ($15 million) because the company sold products not entered in the Australian Register of Therapeutic Goods (ARTG). The penalty is the largest ever assessed for the unlawful supply of therapeutic goods.

Medtronic and the Australian government published a joint statement on the facts of the case. Between 1 September 2015 and 31 January 2020, Medtronic supplied 16,267 Infuse Bone Graft Kit units to 109 hospitals. Medtronic supplied the kit with a metallic spinal fusion cage. The change was entered in the ARTG, but the kit was not. Medtronic admitted its kit supply contravened the Therapeutic Goods Act.

“During the Relevant Period, there was significant clinical demand for the Kit by itself (including for use together with another cage); there was no real clinical demand for the Kit and Cage together. As the Kit alone was not entered in the ARTG, its supply without the Cage was a contravention of s 19D of the Act,” according to the court order.

The kit contained a protein intended to promote bone growth and a sponge intended to act as a carrier for the protein/scaffold for new bone growth. The kit can be used in a wider range of procedures than the cage.

Medtronic packaged the kit and cage separately. Concerns about standalone kit supply were raised at the company in 2009, and a standard operating procedure was established. However, no evidence exists that training occurred or senior managers undertook further checks between early 2010 and early 2020. In 2018, Medtronic withdrew the cage from the market but continued to sell the kit.

The Department of Health wrote to Medtronic in early 2020 after private health insurers raised concerns about using the kit without the cage. Medtronic stopped supplying the kit shortly after receiving the letter.

Medtronic, which must also pay AU$ 1 million toward legal costs, has updated its processes for products that cannot be supplied in Australia in the form in which they are manufactured and has taken steps to improve communication between the quality and regulatory affairs teams and business units.

TGA Notice, Court Order

DRAP seeks feedback on draft updates to Pakistan’s pharmacovigilance guidelines

The Drug Regulatory Authority of Pakistan (DRAP) has released for consultation draft updates to guidelines on its National Pharmacovigilance System (NPC).

NPC is a full member of the World Health Organization’s (WHO) international drug monitoring program. DRAP has drafted the third version of the guidelines, considering the WHO recommendations made during its assessment of DRAP’s national regulatory system.

“As per WHO recommendation and DRAP’s authority decision, the [Pharmacovigilance Risk Assessment Expert Committee] has now been given an advisory role in relation to signal management and risk assessment; whereas, the NPC has been mandated to perform signal management and risk assessment process and to make decisions in the context of risk minimization and recommendation of regulatory actions to concerned boards and committees of the DRAP,” Pakistan’s drug regulator said.

DRAP, which uploaded the draft document on 16 September, seeks feedback for 15 days.

DRAP Notice

Malaysia’s NPRA updates 10-year-old bioequivalence inspection guidelines

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published the second edition of its guideline on bioequivalence inspections.

NPRA published the first edition in 2014. Since then, “many processes related to the inspection of bioequivalence centers have been improved and updated,” NPRA director Rosilawati Ahmad wrote in the guideline. The second edition consolidates the changes to better guide bioequivalence centers' application and inspection process.

The agency has provided more information on the inspection application process, related fees and scope of assessments. Ahmad said, “The goal is to provide context and structure to the inspection process and enhance transparency while providing a comprehensive and contemporary framework that facilitates the inspection process.”

The draft released for consultation includes changes such as adding a section on different categories of bioequivalence inspection, such as study-specific and extraordinary inspections.

NPRA Guidelines

Philippine FDA responds to feedback on drug product and API registration rules

The Philippine Food and Drug Administration (FDA) has detailed its actions in response to feedback on the registration of drug products and active pharmaceutical ingredients (APIs) for human use.

One of the updated rules and regulations' main goals is to address “the issue of the accumulating number of applications not being processed in a timely manner,” FDA said. In a 132-page document, FDA listed the feedback on its attempt to address that issue and other problems, plus its replies to the comments.

The administration’s responses reveal part of the regulatory roadmap for building on the rules and regulations. FDA plans to develop a separate policy and system for pre-assessment that applies to all its centers to ensure it has “a regularly updated uniform application platform.”

FDA is also planning to publish specific guidelines through circulars. The administration said there are too many product types, each with different requirements, timelines, and fees, covered by the rules and regulations to list them in a single document.

FDA Notice

Asia-Pacific Roundup: India updates pharmacovigilance guidance, extending event reporting deadline

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