Insights

REGISTRATION OF MEDICINES IN THE EURASIAN ECONOMIC UNION

After the Decision No. 78 of the Board Eurasian Economic Commission (EEC) oN November 3rd, 2016, the “Rules” for registration and expert review of drugs for medical use within the Eurasian Economic Union (EAEU) were approved and entered into force on May 6th, 2017.

With a view to theese forthcoming changes, medicines registered under the “Rules” can circulate and be offered for sale throughout the EAEU, in the territories of Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan without undergoing any registration procedures in each of these member states.

In particular, the “Rules” provide two procedures for registration of medicines:

1) Mutual recognition: the registration is first conducted in the reference state at the applicant's choice, then in the states of recognition at the applicant's request;

2) Decentralised procedure: the registration is conducted simultaneously in several member states in which an application has been filed, one of which is chosen as the reference state.

 

In addition, for registration dossiers of medicines registered in the member states under the national requirements before 31 December 2020, it is necessary to conduct the Bringing into Compliance procedure with the EAEU requirements until 31 December 2025.

In case the drug product was registered before 31.12.2020 and marketed in at least three member states for five years, an unlimited MA will be issued, after the approval of the above mentioned procedure.

 

Regulatory Pharma Net team and experts have years of experience in identifying the best solutions and are available to support companies with the preparation of the registration dossiers and to conduct the “Bringing into Compliance” procedure. We would be happy to respond to any of your inquiries.

For further information you are welcome to visit us at BOOTH B 37 at DIA Europe 2019 or sending your request to info@regulatorypharmanet.com we could arrange a dedicated meeting or teleconference.

 

Regulatory Pharma Net team is available to support companies to comply with this requirement.

Michele Manetti 25-01-2019

Insights

EUROPEAN REGULATION 2017/745 – Clinical evaluation: new requirements for equivalence demonstration

The European regulation 2017/745, that will entry into force in May 2020, introduces several new elements with an impact on many aspects of the medical device field, including the clinical evaluation.

Chapter VI and Annex XIV of the European regulation 2017/745 are dedicated to the clinical evaluation.

 

One of the most interesting change concerns the requirements which have to be fulfilled for demonstrating the equivalence between two different devices.

 

In this regard, according to Article 61 of the new Regulation, a manufacturer can demonstrated that a device is equivalent to an already marketed one, provided that the following conditions are met:

  • the two manufacturers have entered into a contract expressly allowing the manufacturer of the second device full access to the technical documentation;
  • the original clinical evaluation has been carried out in compliance with the requirements of the new Regulation, and the manufacturer of the second device provides clear evidence of this to the notified body.

 

The technical, biological and clinical characteristics that shall be considered for the demonstration of equivalence are described in the Annex XIV:

  • Technical characteristics: the device has similar design, specifications and physic-chemical properties and it is used under similar conditions of use.
  • Biological characteristics: the device uses the same materials or substances in contact with the same human tissues and it has similar duration and release characteristics of the substances, including degradation products and releasable substances.
  • Clinical characteristics: the device is used for the same clinical indication or purpose, including similarity of severity and stage of disease and it has the same type of users and range of population. Furthermore, it must offer a similar performance in view of the clinical effects expected for a specific intended use.

 

If all these requirements are fulfilled, the manufacturer may avoid carrying out a clinical investigation on the device.

 

This may have a great impact on the company’s activities, as there are many devices whose clinical evaluations are based on the demonstration of the equivalence with other devices. Therefore, manufacturer should carefully check and plan all the needed activity to be compliant  with the new regulation.

 

Don't get caught unprepared!

 

Regulatory Pharma Net is available to support companies for the identification of a proper clinical evaluation strategy, as well as, to provide additional information and advice on quality and regulatory aspects to be compliant to the new Regulation 2017/745.

Michele Manetti 14-05-2019

Insights

MEDICAL DEVICE – European Regulation 2017/745 – Clinical Evaluation: focus on class III medical devices

Among the several main innovations news introduced with European Regulation 2017/745 regarding clinical evaluation topic, it is important not to underestimate the stricter standards to be fulfilled by the manufacturers of class III medical devices, from May 2020.

Generally, a clinical investigation is required for a class III device, except the following cases:

  • the device has been designed thorough modifications of an already marketed device by the same manufacturer;
  • the modified device has been proved equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and
  • the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.

Should all the above conditions be fulfilled, the notified body will just have to to check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.

A clinical evaluation might be avoided also in case of class III devices: which have been lawfully placed on the market in accordance with Directive 93/42/EEC and for which the clinical evaluation is based on sufficient clinical data. In these cases, the Notified Body is required to check if adequate clinical data are included in the clinical evaluation. However, if the clinical data reported are considered insufficient, the Notified Body can ask for additional clinical data and a clinical investigation may be needed.

Another important innovation is reported in Article 61. According to Article 61, chapter VI, for all class III (and also class IIb) devices, the manufactures are allowed, prior to the relevant clinical evaluation and/or investigation, to consult an expert panel with the aim of reviewing the manufacturer's intended clinical development strategy and proposals for clinical investigation. The manufacturer shall give due consideration to the views expressed by the expert panel and such consideration shall be documented in the clinical evaluation report.

 

Based on these points, each class III manufacturer should carefully evaluate the best strategy to be adopted prior to perform the relevant clinical evaluation activities.

 

Don’t get caught unprepared!

 

Regulatory Pharma Net is available to support companies for the identification of a proper clinical evaluation approach, as well as, to provide additional information and advice on quality and regulatory aspects to be compliant to the new Regulation 2017/745.

 

 

 

 

 

Michele Manetti 18-06-2019

Insights

MEDICAL DEVICES – POST MARKET SURVEILLANCE: THE INTRODUCTION OF PERIODIC SAFETY UPDATE REPORT

As part of an ever-increasing improvement in post-marketing surveillance activities for medical devices, the new EU regulation 2017/745 introduces the obligation for the manufacturers of class IIa, IIb and III to prepare a periodic safety update report (‘PSUR’) for each device (and where relevant for each category or group of devices) reporting the results and conclusions of the analyses of the post-market surveillance data together with the description of any preventive and corrective actions relevant to safety.

 

Manufacturers of class IIb and class III devices will have to update the PSUR at least annually and, except in the case of custom-made products, the document is part of the technical documentation as specified in Annexes II and III. Otherwise, manufacturers of class IIa devices will update the PSUR when necessary and at least every two years.

Lastly, for custom-made devices, the PSUR will be part of the documentation referred to in Section 2 of Annex XIII.

 

The PSUR will report:

  1. Information on feedbacks from the market and incidents reported in the concerned period
  2. the conclusions of the benefit-risk determination
  3. the main findings of the PMCF (if any)
  4. the volume of sales of the device and an estimate evaluation of the size and other features of the population using the product (and, where practicable, the relevant usage frequency)

 

A common PSUR template to be used in all EU countries is currently under revision at central level and it will be available in the next months.

 

In case of class III devices or implantable ones, manufacturers will have to submit PSURs in the EUDAMED database (once it will be available); the notified body involved in the conformity assessment will access to the document through EUDAMED. The notified body will review the report and add its evaluation in EUDAMED specifying the details of any action taken. It remains to be defined the timing requested by the Notified Body to evaluate the PSUR. It should also be noted that the PSURs and the evaluation by the notified body will be made available to competent authorities through EUDAMED, upon request.

 

Regulatory Pharma Net is available to support companies for the identification of a proper post-marketing surveillance strategy and PSUR preparation, as well as, to provide additional information and advice on quality and regulatory aspects to be compliant with the new Regulation 2017/745.

 

Michele Manetti 17-07-2019

Insights

CONVERTING CENTRALLY AUTHORISED PRODUCTS (CAPS) TO UK MARKETING AUTHORISATIONS (MAS)

After Brexit became effective on 1st January 2021, all existing EU product MAs obtained through Centralized procedure (CAP) have been automatically converted into UK MAs (“grandfathering”) effective in Great Britain (only) and issued with a UK MA number on 1st January 2021. As a result of the implementation of the Northern Ireland Protocol, existing CAPs will remain valid for marketing products in Northern Ireland.

In light of this, the challenge for companies is to complete the action plan transversally involving several functions (RA, PV, QA and Supply Chain) to fulfil all the obligations requested by MHRA. These obligations, which have different deadlines for implementation, include:

  • Company registration into MHRA portal and initiating sequence submission within the period of one year starting on 1st January 2021.
  • Change of ownership application to establish an MAH in the UK within 24 months starting on 1 January 2021.
  • New UK artworks creation within 36 months in total from 1st January 2021 to ensure all stock released to market is in compliant packaging.

PV Activities management and UK based QPPV contact person. From 1st January 2021 the MAH will be responsible for submitting the following pharmacovigilance data and documentation to the MHRA for medicines authorised in GBMoreover, MAH must nominate a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV within 12 months from 1st January 2021.

Regulatory Pharma Net team is available to fully support companies in preparing and implement the appropriate cross-functional action plan to make any Marketing Authorization compliant to the MHRA requirements.

Michele Manetti 27-08-2021

Insights

IRISH LANGUAGE DEROGATION ENDING ON 1ST JANUARY 2022 AND NEXT STEPS FOR IRISH MARKETING AUTHORIZATION HOLDERS

Following the European Commission report published in June 2021, it was confirmed that no capacity problems are foreseen for translations as of 2022 and, as result, the derogation for the Irish language (obligation to translate the opinion page and the product information annexes) will be finally lifted in January 2022.

This means that from January 2022 onwards every new MAA Human and Veterinary will have to include the annexes in the Irish language and decisions of the European Commission addressed to EU Member States, including the product information they contain, will be translated into Irish together with the other official EU languages, for the following procedures:

  • Referrals
  • Periodic safety update reports (PSURs)
  • Post-authorisation safety studies (PASS)

Irish will also be the authentic language of Commission decisions addressed to any MAH established in Ireland, unless they request a language waiver using an appropriate template, by which they request to use English as authentic language. The waiver will be valid for a period of 3 years from the date of notification and will be automatically renewed for further consecutive periods of 3 years, unless the companies or individuals decide to withdraw the waiver. The withdrawal of the waiver will take effect at the end of the three years period or three months after it has been notified, whatever is earlier. Marketing Authorisation holders should regularly review the corresponding information and update the waiver, as needed.

The concerned companies or individuals (in case of orphan designations) are requested to submit their waiver by 31 January 2022.

Regulatory Pharma Net team has successfully provided assistance in centralized procedures and is also available to support Irish companies with language waiver request and submission by advising on next steps to be fulfilled.

Michele Manetti 16-12-2021

Insights

CHINESE NPMA ANNOUNCEMENT ON IMPLEMENTING THE APPLICATION WITH ELECTRONIC COMMON TECHNICAL DOCUMENTS

As of 29 December 2021, the marketing authorization of chemicals with Registration Categories 1 and 5.1, therapeutic biological products with Registration Category 1 and preventive biological products with Registration Category 1 may be applied according to eCTD, according to the last disposals of Chinese National Medical Product Administration (NMPA).

In particular the applicants should prepare and submit the eCTD application dossiers on CD-ROM as required by the eCTD technical documents and submit the paper dossiers within 5 working days upon the acceptance of the eCTD registration application dossiers.

If an applicant fails to submit the paper dossiers within the specified time, the drug registration process will be automatically terminated.

At the same time, the applicant should make a commitment that the electronic dossiers submitted is completely consistent with the paper dossiers with the applicant that should bear the responsibilities for any problem arising from the possible inconsistency.

However, in order to ensure a steady promotion of the eCTD and minimize its impact on the application, applicants can still choose the existing registration method for the above registration applications.

The relevant technical guidance may be accessed on the website of the Center for Drug Evaluation of NMPA.

RPN constantly monitors the main updates coming from the major worldwide Regulatory Authorities and is available to support Companies in defining the best regulatory solutions.

Reach out to us at info@regulatorypharmanet.com

Michele Manetti 08-04-2022

Insights

Navigating the Transition: The Evolution of Regulatory Procedure Management in Product Lifecycle Management towards IRIS

The landscape of Product Lifecycle Management (PLM) is undergoing a significant transformation, especially in the realm of Regulatory Procedure Management (RPM). This evolution is primarily driven by the transition towards the Innovative Regulatory Information System (IRIS), a move that promises to streamline processes, enhance transparency, and foster a more efficient regulatory environment.

Regulatory Procedure Management (RPM) is a critical component of Product Lifecycle Management (PLM) in the pharmaceutical and medical device sectors. RPM encompasses the strategies, processes, and documentation required to navigate the complex regulatory landscape effectively. As regulatory requirements become more stringent and global markets more interconnected, the need for an integrated and innovative approach to RPM has never been more apparent.

Challenges and Opportunities of the IRIS Transition:

The transition to IRIS represents a pivotal shift in RPM, offering a range of benefits from streamlined submission processes to real-time tracking of regulatory status. This digital leap forward is set to revolutionize the way companies manage their regulatory procedures throughout the product lifecycle. The main benefits of the transition will be:

  • Enhanced Efficiency: IRIS promises to reduce the complexity and time required for regulatory submissions through standardized procedures and digital workflows.
  • Increased Transparency: With features like real-time status updates, stakeholders can now have greater visibility into the regulatory process, enhancing accountability and decision-making.
  • Improved Compliance: The system's structured and integrated approach facilitates better adherence to changing regulatory requirements, minimizing the risk of non-compliance.
  • Global Harmonization: IRIS supports international standards, making it easier for companies to manage regulatory procedures across different regions.

Despite the clear benefits, the transition to IRIS is not without its challenges. Companies must navigate the technical and organizational hurdles associated with adopting a new digital system. This includes training staff, updating internal processes, and ensuring data integrity during the migration. Moreover, as with any significant change, there may be resistance within organizations, underscoring the need for clear communication and change management strategies.

The advancement in Regulatory Procedure Management towards the Innovative Regulatory Information System (IRIS) signifies a major step forward in the realm of Product Lifecycle Management.

This journey is not just about regulatory compliance but also represents a strategic opportunity to set a new standard of excellence within the industry.

Regulatory Pharma Net is closely monitoring and experiencing the evolving PLM landscape in medicinal products and medical devices and can support companies, both strategically and operationally, to adapt to the ongoing transition, overcoming the challenges to fully benefit from IRIS.

 

 

Michele Manetti 19-03-2024