India has proposed regulatory reforms designed to encourage R&D and innovation in the pharmaceutical and medical industries. The proposals are part of a larger plan to make India a leader in the discovery of innovative drugs and medical devices by creating an entrepreneurial environment in the country.

Working towards this goal, the Department of Pharmaceuticals (DoP) proposes to simplify India’s regulatory processes to enable rapid drug discovery and innovation in medical devices. According to the DoP, the Indian framework must extend beyond “traditional regulatory objectives of safety and quality” by starting to “differentiate in favor of innovation”.

The DoP identified obstacles to achieving its goal. First, the ministry determined that the presence of “multiple agencies with different mandates and expertise that an innovative firm must navigate” means that new products and innovations that “do not fit into existing standards” may lack ” clear processes ”. The DoP said India’s amended clinical trials and medical device rules fill some of the loopholes, but not all.

Second, the DoP said regulatory capacity in government needs to keep pace with scientific and technological advancements, thereby enabling authorities to become less dependent on “ad hoc external inputs.” The lack of in-house expertise in emerging areas “contributes to long approval times for innovative products,” the DoP said.

Faced with the challenges, the DoP proposes to create a Common Specific Procedure Pathway (CSPP) for each class of product. The path would include “checklists, time limits, parallel processing, joint inspections, automatic / deemed approvals and data sharing between regulators”. The CSPP is part of the department’s plans to get regulators to work together, reduce duplication and thereby reduce approval times for innovative products by at least 50% over the next two years.

DoP is also proposing to create a digital portal, hosted by the Central Drugs Standard Control Organization (CDSCO) of India, which will serve as a single interface between innovators and all agencies involved in overseeing the development and approval of their products. The portal will automate the transfer of data between departments and use “artificial intelligence-based file review and gap identification… to improve efficiency and reduce human interface”. The ultimate goal of the portal is to bring transparency, speed and predictability to regulatory processes and outcomes.

Other aspects of the proposal relate to regulatory capacity and legislation. DoP wants to strengthen CDSCO with “project management roles to provide dedicated support to industry innovators”. This aspect of the strategy includes adding expertise in biopharmaceuticals and “high-end medical devices”. The DoP also wants the National Pharmaceutical Pricing Authority of India to add expertise “in pricing innovative new products, while pursuing affordability as an overarching goal.”

Finally, the DoP proposes to review the legislation covering biopharmaceutical and medical R&D. The plan is to eliminate inconsistencies and redundancies, for example by exempting certain products from India’s Biodiversity Act and allowing CDSCO and state regulators to conduct joint inspections.

The project is open for comments until November 6.

Draft policy

TGA Updates Approach to GMP Monitoring of Foreign Manufacturers as COVID-19 Drags on

Australia’s Therapeutic Goods Administration has updated its Good Manufacturing Practices (GMP) approach to foreign manufacturers during the COVID-19 pandemic in light of current limitations on its overseas operations.

Last year, TGA placed remote inspections at the center of its revised approach to GMP. Today, TGA is working on “a large number of Certification requests following the suspension of GMP inspections abroad” and is adapting its approach. TGA no longer contacts sponsors before including them in its remote inspection program as there is no other option for certification requests.

The volume of work has led TGA to prioritize remote GMP inspections based on the possibility of using alternative GMP authorization processes, current compliance information and marketing authorization requests.

Regarding alternative processes, TGA still allows manufacturers who had an on-site inspection in 2018/2019 to complete a GMP authorization questionnaire to verify their compliance. TGA revised the policy in light of the lack of in-person inspections by its regulatory peers, allowing companies to file inspection reports remotely to support or, in some cases, replace the GMP authorization questionnaire. However, remote inspection reports cannot be used as primary proof of GMP authorization.

The guidelines also address the “large number of GMP authorizations” which are due to expire at the end of the year for reasons related to TGA’s mutual recognition agreement partners, including the European pandemic guidelines. TGA will extend the validity of GMP authorizations beyond the recommendations of its partners to the extent possible, taking into account such elements as the type of manufacturing steps performed in the facility and the time since the last physical inspection in her decision.

TGA Guide

Pakistan issues draft guidelines on imports and exports of therapeutic products

The Pakistan Medicines Regulatory Authority (DRAP) has issued draft guidelines outlining requirements for commercial import and export of therapeutic products, including finished products and active ingredients.

The DRAP project covers the documentation needed to move therapeutic products into and out of Pakistan, details on how to determine eligibility for import and export products, and an overview of the procedures. port verification and clearance. Another section of the text describes the responsibilities of the entities involved in importing and exporting.

Different sections of the project deal with the rules relating to pharmaceutical and biological products and, more briefly, to medical devices and alternative medicines. The DRAP has not yet published a timetable for the finalization of the project and the entry into force of the directive.

DRAP notice

TGA adds Bharat and Sinopharm COVID-19 vaccines to list of recognized jabs in Australia

The TGA has added Bharat Biotech’s Covaxin and Sinopharm’s BBIBP-CorV to the list of recognized COVID-19 vaccines in Australia for the purpose of determining whether a traveler is vaccinated.

Neither vaccine is licensed for use in Australia. However, as the country opens up to international travel, it will allow overseas visitors who have received Covaxin or BBIBP-CorV to benefit from the more relaxed requirements placed on people who have been vaccinated against COVID-19.

The vaccines were absent from the list of products initially recognized by TGA. The agency changed its position after receiving “additional information demonstrating that these vaccines offer protection and potentially reduce the likelihood that an inbound traveler will transmit COVID-19 infection to others during their stay in Australia or become seriously ill due to COVID-19 ”.

TGA’s revised policy will particularly affect people in China and India, where both vaccines have been widely used, and therefore have “significant impacts for the return of international students and the travel of skilled and unskilled workers to Australia.”

TGA Notice

Indonesia Becomes First Country To Authorize Novavax’s COVID-19 Vaccine

Novavax has finally obtained authorization for its COVID-19 vaccine. Indonesia has become the first country to grant Emergency Use Authorization (EUA) for the COVID-19 vaccine made from recombinant protein nanoparticles.

EUA comes 10 months after Novavax released landmark data from a UK Phase 3 clinical trial of 15,000 subjects and more than four months after the company provided results from a US study wider. Both trials found the vaccine to be around 90% effective, albeit against different variants than those circulating today, but manufacturing issues delayed filings.

Novavax expects EUA in Indonesia, where the Serum Institute of India sells the vaccine, to be the first of many authorizations in the coming weeks. While many countries have already vaccinated their populations, Novavax’s vaccine storage requirements mean that it could play a role in parts of the world lacking freezing cold chain capabilities.

Press release

© 2021 Society of Regulatory Affairs Professionals.

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