Israel Embarks on Partnership with FDA’s Project Orbis, Generic Drug Cluster

Date: July 29, 2021 | Country: AUSTRALIABRAZILCANADA-ONTARIOISRAELSINGAPORESWITZERLANDUNITED KINGDOMUNITED STATES | Region: ASIA & SOUTH PACIFICEUROPEMIDDLE EASTNORTH AMERICASOUTH AMERICA | Type: Policy | Keywords: #fda #generic #genericdrugcluster #projectorbis

PRICENTRIC BRIEF:

  • Israel’s Division of Medical Technologies, Information, and Research has joined the United States Food and Drug Administration (FDA) in its Project Orbis and Generic Drug Cluster initiatives, announced the Israeli Ministry of Health
  • Project Orbis is a collaborative initiative of the FDA’s Oncology Center of Excellence (OCE) which allows for concurrent submission and review of oncology drugs among the regulatory agencies of the US, Switzerland, Australia, Canada, Singapore, and, most recently Brazil and the United Kingdom
  • Led by the FDA’s Global Generic Drug Affairs program, the Generic Drug Cluster is the first forum established to address generic drug development globally, as well as increase scientific alignment among leading drug regulatory agencies, with the aim of discussing policy and guidance

THE DETAILS

JERUSALEM, Israel – Israel’s Division of Medical Technologies, Information, and Research has joined the United States Food and Drug Administration (FDA) in its Project Orbis and Generic Drug Cluster initiatives, announced the Israeli Ministry of Health.

Project Orbis is a collaborative initiative of the FDA’s Oncology Center of Excellence (OCE) which allows for concurrent submission and review of oncology drugs among the regulatory agencies of the US, Switzerland, Australia, Canada, Singapore, and, most recently Brazil and the United Kingdom.

As mentioned, Orbis allows for concurrent filing of oncology drugs among participants and subsequent dialogue on the examination of these regulatory filings. According to Israel’s health ministry, guidance detailing the requirements and guidelines of the project will be issued soon.

Led by the FDA’s Global Generic Drug Affairs program, the Generic Drug Cluster is the first forum established to address generic drug development globally, as well as increase scientific alignment among leading drug regulatory agencies.

The Cluster is guided by four initiatives:

  1. Achieving common understanding of each regulatory agency’s requirements for approval and current standing on topics related to generic drug development via information sharing on these requirements and recommendations outlined in guidance documents
  2. Offering a confidential forum for discussing policies in development, including draft guidance, as well as the scientific basis for these decisions
  3. Providing a forum for discussing both general and product/class-related scientific review issues to foster greater alignment in approaches to scientific evaluation
  4. Addressing long-term safety issues to create a global safety net for generic drugs by sharing confidential safety reports.

Along with US, UK, Swiss, European, and Canadian authorities, Israel will focus on policy recommendations and harmonizing regulatory requirements in the field of generic medicines.

The Ministry of Health stated: “This is another step of the division to expand international cooperation, strengthen the position of Israeli regulation, and promote innovation as a relevant player in the international arena.”

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