23.07.2022

Apply for SME status today!

ADRES EU, the European subsidiary of ADRES, can provide your company with valuable scientific and regulatory assistance through a simple, quick, and inexpensive process!

Between 2016-2020:

The success rate for SME marketing authorization applications for human medicines more than doubled, reaching 89% in 2020
More than 4 in 10 medicines selected for EMA’s PRIME: priority medicines scheme were from SMEs
SMEs developed nearly 20% of all human medicines recommended for authorization in 2020; half of these target a rare disease.

The European Medicines Agency (EMA) offers different incentives for micro, Small and Medium-sized Enterprises (SMEs). SMEs are eligible for consideration in EU expedite-development programs, as well as to receive regulatory, financial, and administrative assistance supporting the product development process, including:

Regulatory, administrative, and procedural assistance including SME briefing meetings
Fee reductions for scientific advice, scientific services, and inspections
Fee exemptions for certain EMA administrative services
SMEs can apply for a PRIME on the basis of compelling pre-clinical data and tolerability data from initial clinical trials instead of clinically meaningful improvement of efficacy
Certification procedure at any time during the development of an ATMP
Approaching the Innovation task force, which provides a platform to open an informal dialogue with the Agency and proactively identify scientific, legal and regulatory issues arising from their developments
Deferral of the fee payable for an application for marketing authorization and related activities (e.g., inspections, translations of the product information)
Fee reductions and exemptions for post-authorization procedures and pharmacovigilance activities
and more…

SMEs are enterprises that meet the following criteria:

Employ fewer than 250 persons and
Have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million.

So, what do you need to do? Almost nothing!

Step 1. Write us to: tanya@adres.bio

Step 2. We will assess your organization’s eligibility for SME status

Step 3. If eligible, we will request an SME status for your organization (to be annexed to ADRES EU).

It takes approximately one month to obtain an SME status, while no EMA fee is required.

https://www.youtube.com/watch?v=Zp-zMrzuLOs [LIY1] This is an explanation of SME status by the EMA

23.07.2022

FDA’s New Advanced Therapies “Super Office” to Benefit Medical Startups – Biotech Regulatory Solutions.

In mid-September, the US Food and Drug Administration (FDA) announced that the Office of Tissues and Advanced Therapies (OTAT) will become the Office of Therapeutic Products (OTP). The organizational changes, which were approved in August and went into effect on September 16, are far more than just a name change. In this era of rapid advancement, biotech regulatory consulting plays a crucial role in navigating FDA changes.

OTP, which like OTAT is part of the FDA’s Center for Biologics Evaluation and Research (CBER), will be elevated to a Super Office. This will allow CBER to manage the program at a macro level and better position the center to address an ever-changing public health landscape. These changes are not just significant locally but will influence global regulatory services and their strategies.

The new organizational changes will improve functional alignment, increase the review capabilities of the organization, and enhance expertise on new cell and gene therapies. It will also include more full-time staff and supervisory positions, as well as avoid the need for continual reorganizations.

This organizational change is welcome news to startups, who often encounter delays while waiting for FDA approval. Super Offices, which have been created over the past decade, are often more efficient as they tend to optimize combined functions that had been taking place in separate departments.

At ADRES, we believe that biopharmaceutical companies and startups involved in the development of cell and gene therapy will see a far more streamlined approval process, with more transparency in the process. Companies should expect to see an expedited drug development and review process, particularly for promising pipeline products.

Discover how we can help you get to market faster! Talk to us today.