Authored by Dr. Liron Gibbs-Bar

Embarking on the regulatory affairs journey of bringing a new medicinal product to the market is no small feat. The road is long and filled with regulatory hurdles, especially when aiming to meet the high standards required for regulatory approval and market access. However, there’s a beacon of hope for applicants, particularly those in the academic sector and small to medium-sized enterprises (SMEs): the PRIME scheme by the European Medicines Agency (EMA).

Launched in 2016, the PRIority MEdicines (PRIME) scheme represents a pivotal shift in the EMA’s approach to medicinal regulation. Its primary goal is straightforward yet ambitious: to offer continuous scientific and regulatory guidance, coupled with an accelerated assessment process for new medicines that target unmet medical needs and hold significant public interest.

For researchers and companies working on groundbreaking treatments, PRIME offers a unique opportunity. Early Entry PRIME status can be a game-changer, especially for SMEs and academic applicants. This status is granted when proof of principle is demonstrated, opening doors to invaluable guidance from regulators early in the development process.

The EMA’s recent revision to the PRIME guidelines introduces several key features to enhance the scheme’s effectiveness:

1. Pre-submission meetings to assist applicants in planning their PRIME application.
2. Expedited follow-up scientific advice with shortened timelines, providing quicker access to essential guidance.
3. A submission readiness meeting about a year before the marketing authorization application (MAA) filing date, offering a platform to discuss the development status and readiness of the marketing application dossier.
4. A revamped approach involving the submission and maintenance of a regulatory roadmap and product development tracker, taking the place of the PRIME annual update.

These enhancements are designed to deepen knowledge, and support accelerated assessments, significantly benefiting those navigating the complex waters of medicinal product development.

At ADRES, we understand the intricacies of the regulatory landscape, including the PRIME designation. Our team has extensive regulatory submissions experience, catering to SME and non-SME companies. 

We recognize the challenges and opportunities of seeking PRIME status and are equipped to guide you every step of the way.

Navigating the PRIME pathway can be daunting, but with proper support and guidance, it’s a journey you can embark on with confidence. 

You’ve got this!

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

The pharmaceutical and biotech industries operate in a highly regulated environment, where compliance with stringent regulatory requirements is essential. To navigate this complex landscape successfully, companies often turn to Regulatory and development consulting services. ADRES, a reputable consulting firm, specializes in providing comprehensive solutions tailored to the unique needs of the pharmaceutical and biotech industry. With their expertise, ADRES empowers organizations to achieve regulatory compliance and drive innovation forward.

The Significance of Scientific and Regulatory Consulting Services:

Scientific and Regulatory consulting services have become indispensable for the pharmaceutical and biotech industries. These services encompass a wide range of expertise and support to assist companies in meeting the intricate regulatory requirements governing drug development, manufacturing, and distribution. ADRES recognizes the critical role of regulatory compliance in these sectors and offers specialized services to address the unique challenges faced by pharmaceutical and biotech companies.

Regulatory Affairs Consultants for the Pharma industry:

ADRES boasts a team of experienced pharma regulatory consultants who possess a deep understanding of the complex regulatory landscape. These experts assist organizations in navigating the regulatory pathways for drug approvals, providing guidance on compliance with regional and international regulatory standards. ADRES’ consultants stay updated with the latest regulations, ensuring clients receive accurate and timely advice to expedite the approval process while maintaining compliance.

Tailored regulatory solutions for biotech companies.

Biotech companies often face distinct regulatory challenges due to the innovative nature of their products. ADRES recognizes these challenges and provides Tailored regulatory solutions to biotech companies.These solutions encompass strategic advice on regulatory strategies for novel therapies, assistance in preparing regulatory submissions, and support in navigating regulatory hurdles unique to the biotech industry. By leveraging ADRES’ expertise, biotech companies can streamline their regulatory processes and accelerate time to market.

Compliance Audits and Remediation:

ADRES offers comprehensive compliance audits to evaluate the regulatory status of pharmaceutical and biotech companies. Through meticulous assessments, ADRES identifies potential compliance gaps and recommends remediation strategies. This proactive approach helps organizations address deficiencies before regulatory inspections, minimizing the risk of penalties and disruptions to operations.

Global Regulatory Strategy:

Navigating global regulatory requirements can be challenging for pharmaceutical and biotech companies with an international presence. ADRES assists clients in developing robust global regulatory strategies, taking into account regional variations, harmonization initiatives, and market access considerations. This ensures that organizations can streamline their regulatory processes across multiple jurisdictions, minimizing complexity and maximizing market opportunities.

Regulatory compliance is paramount for success in the pharmaceutical and biotech industries. ADRES, a leading regulatory consulting firm, offers tailored solutions to empower organizations in meeting regulatory requirements and driving innovation. With a team of expert pharma regulatory consultants and a focus on specialized biotech regulatory solutions, ADRES enables companies to navigate the complex landscape effectively. Through services such as compliance audits, global regulatory strategies, and remediation support, ADRES ensures that pharmaceutical and biotech companies can focus on their core objectives while maintaining compliance and achieving regulatory success.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

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Watch our Joint Webinar with Protagene on “Regulatory Aspects of Comparability Exercise,”

ADRES is a leading international consulting and execution firm dedicated to regulatory affairs, QA, Medical QA, and CMC. We provide a comprehensive resource hub for professionals seeking information, services, and training in regulatory affairs. With a focus on regulatory compliance, guidelines, and strategies, ADRES’s regulatory affairs professionals offer valuable insights and expertise to navigate the complex Biotech landscape. From product registration to quality assurance, ADRES supports startups and companies in staying up-to-date and ensuring regulatory compliance in various life sciences industries.

We are thrilled to invite you to watch an exclusive video by ADRES on the topic of “Regulatory and Analytical Aspects of Comparability of Biological Products.” This video offers valuable insights into the intricate world of regulatory frameworks and analytical approaches in ensuring the comparability of biological products.

By watching this video, you will gain a comprehensive understanding of the challenges, best practices, and emerging trends in this critical field. The content covers regulatory requirements, analytical techniques, case studies, and future directions, providing you with the latest knowledge and industry expertise.

We believe that this video will be a valuable resource for professionals, researchers, and anyone interested in the regulatory and analytical aspects of the comparability of biological products. Don’t miss out on this opportunity to enhance your knowledge and stay up-to-date with the advancements in the field.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us. We look forward to hearing your feedback and insights after watching the video.

Thank you for your attention, and we hope you will find the video informative and insightful.

We are excited to offer you an additional resource to complement the video on “Regulatory and Analytical Aspects of Comparability of Biological Products” by ADRES. In addition to the video, we have prepared a downloadable PDF file presentation summarizing the key points covered in the video.

The presentation serves as a concise and visual summary of the important concepts, regulatory frameworks, analytical approaches, and case studies discussed in the video. It offers a convenient way to revisit and reinforce your understanding of the topic at your own pace.

To download the presentation, please click on the following link.

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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