The Israeli National Bioconvergence Program

Tailored Regulatory Support for Breakthrough Bioconvergence Technologies

As part of the National Bioconvergence Program, the Ministry of Health is pleased to announce the expansion of its dedicated regulatory support for companies developing advanced medical technologies that combine biology with engineering and/or computational approaches (Bioconvergence). The program offers tailored, focused regulatory guidance provided by the Clinical Trials Department at the Ministry of Health. The purpose of this support is to bridge regulatory gaps at early stages of development and enable the efficient and safe transition of bioconvergence technologies from preclinical development to first-in-human (FIH) clinical trials in Israel. Target Audience and Regulatory Support Target audience: Bioconvergence companies at the preclinical development stage of an innovative technological product which, due to its unique characteristics, does not fit within existing regulatory pathways for clinical trial approval. Support provided under the program: Development of a dedicated, product-specific regulatory framework that enables the creation of a structured and tailored pathway toward approval, without compromising professional or safety standards. Eligibility Criteria and Program Fit The program is intended for projects with significant potential impact that meet the following criteria: Israeli R&D: The majority of the company’s research and development activities are conducted in Israel. Development stage: Preclinical stage, prior to the submission or approval of a clinical trial application for the product in Israel or abroad. Clinical readiness: The company is expected to be able to submit a complete clinical trial application within two years from the start of the regulatory support. Regulatory innovation: Breakthrough products for which no established regulatory pathway currently exists in Israel or internationally. Connection to Israel: A commitment to conduct the clinical trial in Israel. Preference will be given to companies that also declare their intention to continue development activities in Israel. Fields of activity: Bioconvergence as defined under the National Bioconvergence Program, excluding xenograft components. Program Admission Process Applications to join the program will be reviewed discreetly and professionally: Initial inquiry: Submission by email of a product description, together with an explanation of how the company meets the eligibility criteria and fits the program. Eligibility assessment: Professional evaluation of the company’s compliance with the eligibility criteria and overall suitability for the program. Kick-off meeting: For companies found suitable, an initial working meeting will be held to jointly define the regulatory support framework. Added Value for Participating Companies Participation in the program provides a unique opportunity to work directly with the regulator to define the precise approval pathway required for the product, reduce clinical and regulatory risks at an early stage, and advance the product toward the market in the safest and most efficient manner possible. Contact Details and Applications Representatives of the Ministry of Health and the National Bioconvergence Program are available for inquiries and an initial assessment of program suitability. Email inquiries: Ministry of Health, Clinical Trials Department – [email protected] National Bioconvergence Program – [email protected]