Home Meeting notice Asia-Pacific Roundup: Indian Pharmacopoeia Joins Global Focus Group Pilot

Asia-Pacific Roundup: Indian Pharmacopoeia Joins Global Focus Group Pilot

Regulatory news

| September 13, 2022 | By Nick Paul Taylor

The International Pharmacopoeia Discussion Group (PDG) has accepted the Indian commission in a one-year pilot project that aims to expand its membership beyond the European Union, Japan and the United States.

Almost a year ago, PDG revealed that it was preparing a pilot to integrate other global pharmacopoeias. PDG is currently composed of the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopoeia, with the World Health Organization acting as an observer. Together, the groups have harmonized and maintained 29 general chapters, as well as 46 excipient monographs, since PDG began operations in 1989. The expansion pilot is intended to foster convergence of the global pharmacopoeia.

PDG reviewed applications to join the pilot expansion against criteria that required pharmacopoeias to have equivalent approaches and policies to existing members, apply selected International Council for Harmonization quality guidelines such as Q2, Q3C and Q3D as standards development principles and implement all harmonized general chapters and monographs.

Only one of the candidates met all of the PDG criteria. Acceptance of the application from the Indian Pharmacopoeia Commission (IPC) will see the body join the pilot expansion in October, positioning it to serve as a testing ground for CEO’s plans to expand beyond the EU, Japan and the United States.

While the CEO rejected all other applications, he plans to “keep in touch” with unsuccessful pharmacopoeias regarding “opportunities for collaboration in the future with the aim of achieving greater convergence of global pharmacopoeia standards.” Collaborative opportunities include continuing to share PDG publications, such as draft texts for public comment and final endorsement texts, with non-CEO pharmacopoeias “to support the convergence of these texts beyond the CEO”.

There may also be other opportunities to join the expanded CEO in the future. Established CEO members “will use lessons learned from the year-long expansion pilot to further refine the group’s ways of working and, at the end of the pilot, identify changes needed to ensure the CEO continues to function.” effectively, before wider deployment.

PMDA Notice

Indian panel finds Sanofi failed to conduct study according to approved clinical trial protocol

India’s Expert Committee on Vaccines (SEC) has accused Sanofi of failing to conduct a study of its hexavalent vaccine “in accordance with the approved clinical trial protocol”. The committee concluded that “the clinical study report is not acceptable as presented”.

Sanofi hosted the meeting to discuss next steps for its hexavalent vaccine, which is designed to provide protection against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and poliomyelitis. At the meeting, Sanofi presented the Phase III clinical trial report along with a proposal to seek authorization to administer an intramuscular booster dose in infants aged 12 to 24 months.

“After detailed deliberations, the committee noted that [the] the company did not conduct the study according to the approved clinical trial protocol and the committee recommended that [the] the clinical study report is not acceptable as presented,” the SEC wrote in its minutes of the meeting.

The setback comes about 18 months after the SEC advised that Sanofi has received authorization to manufacture and market the vaccine, “under the condition that [the] The company is expected to continue the ongoing booster dose study and submit safety and efficacy data as they become available. At the 2021 meeting, the committee also indicated that Sanofi’s clinical trial sites could be audited to verify compliance with good clinical practice requirements.

Minutes of meetings

TGA approves Australia’s first combined self-tests for COVID-19 and flu

The Therapeutic Goods Administration (TGA) has approved Australia’s first combined self-tests for COVID-19 and influenza. TouchBio and Fantest received the approvals after presenting clinical and analytical data.

Combination tests that differentiate COVID-19 from influenza could be useful when both pathogens are circulating, given that infection with either can lead to similar symptoms. TGA said that for many consumers, “distinguishing between COVID-19 and the flu is important to managing their infections.”

TGA expects providers to make the tests available for purchase in pharmacies, supermarkets or online. The TouchBio COVID-19 and Flu A/B Rapid Antigen Combo Test is now available for pre-order for shipping in late September. The standard price direct from TouchBio is AU$27 ($18.50), although the company is currently offering the test for AU$24.30.

Like providers of other COVID-19 self-tests, sponsors must provide instructions for use and telephone support. The TGA asks sponsors to provide it with ongoing quality and performance information, including reports of any issues with the use of the tests, such as users experiencing false positives or false negatives, and evidence that they can detect emerging variants of COVID-19.

TGA Reviews

Pakistan’s DRAP adopts action plan to enhance cooperation with other regulators

The Medicines Regulatory Authority of Pakistan (DRAP) has adopted an action plan for medicines regulation developed by the Organization of Islamic Cooperation (OIC). More than 40 OIC members have adopted the plan, which calls for increased cooperation, human resource development and harmonization initiatives.

The OIC counts several Asian countries, including Bangladesh, Malaysia and Pakistan, among its members. Last week, the heads of Member States’ national medicines regulatory agencies, including DRAP CEO Asim Rauf, met in Turkey, leading to the adoption of an action plan for 2022 to 2024 aimed at promoting access to safe, effective and quality medicines. medicines and vaccines.

The Plan of Action includes eight goals related to topics such as cooperation, human resources and creating and strengthening regional and sub-regional harmonization and networking among OIC countries.

Participants also adopted the Istanbul Declaration, which recognizes the challenges posed by the COVID-19 pandemic and the disparity among OIC members. The disparity is linked, in part, to the lack of sufficient drug manufacturing capacity in some countries.

PARD Notice, OIC Notice

India classifies non-sterile portable medical devices in MDR risk categories, 2017

India’s Central Drugs Standard Control Organization (CDSCO) has assigned risk categories to unsterile and invasive surgical instruments used for procedures such as cutting, drilling and sawing. The publication of the list advances the implementation of the Medical Devices Rules 2017.

The list covers “non-sterile, non-powered, portable or hand-operated general purpose surgical instruments intended for use in a variety of general surgical procedures”. This term encompasses four types of medical devices, namely those used for: cutting and dissecting; clamping and occlusion; retract and expose; and grab and hold.

CDSCO has assigned all four groups of surgical instruments to risk category A. Class A is the lowest risk category in India. The low risk of surgical instruments partly reflects the fact that they are intended for transient use, a term CDSCO defines as continuous use for less than 60 minutes.

CDSCO Notice

Other news:

The Philippines Food and Drug Administration (FDA) has restricted parking in its compound to the elderly and those with permanent disabilities. The FDA said a lack of space and “increased daily clearance release schedule” led it to impose parking restrictions, which are intended to support the effective and efficient delivery of public services. FDA Notice

TGA has issued a safety advisory on high levels of lead and other heavy metals in Ayurvedic medicine called Penisole. Taking the drug can lead to lead poisoning. TGA Reviews

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