Tag: ייעוץ רגולטורי

09.01.2023

GMP Annex 1 – Final Revision

𝐓𝐡𝐞 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐔𝐧𝐢𝐨𝐧 𝐫𝐞𝐜𝐞𝐧𝐭𝐥𝐲 𝐢𝐬𝐬𝐮𝐞𝐝 𝐭𝐡𝐞 𝐟𝐢𝐧𝐚𝐥 𝐫𝐞𝐯𝐢𝐬𝐢𝐨𝐧 𝐨𝐟 𝐆𝐌𝐏 𝐀𝐧𝐧𝐞𝐱 1: 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞 𝐨𝐟 𝐒𝐭𝐞𝐫𝐢𝐥𝐞 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬, 𝐕𝐨𝐥. 4 𝐟𝐨𝐫 2022.

Many of the changes are more stringent than in previous versions. For example:

• Separate change rooms are required for entering and leaving production areas if the Contamination Control Strategy (CCS) indicates the risk of contamination is high

• For cleanroom qualification and EM, all grades are required to measure the total particles equal to or greater 0.5 and 5 µm/m3, with instructions to consider 5µm particles measurements where limits are not specified

• For Interventions, all non-qualified interventions should be recorded in the batch record, authorized by the quality unit, and assessed.

We thought the most interesting change required the bioburden samples be taken prior to the first filter if a redundant filtration setup is used.

These are just a few of the changes to the annex. To learn how these and other updates could impact your operations, download our GMP Annex 1 guidelines and reach out.


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22.11.2022

Attention startups in the bio pharma community!

Last week at Adres we hosted our first LinkedIn Live with over 200 participants 🙌

It was great to share our knowledge and experience with the bio pharma community and give you the confidence that you are on the right track with your clinical development program.

In this session, we focused on:

Process Validation and the importance of arriving prepared for this critical milestone

When is the right time to start preparing?

Shifting your mindset to understand the ‘Process is the Product’

Avoiding delays on your critical path

If you weren’t able to join us live, you can still watch the recording here:

Feel free to Contact us for any questions and consultations, we’ll be happy to assist!

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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

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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.

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