The topics addressed were mainly related to system and service development, with special emphasis on EudraVigilance: adverse drug reaction reporting and signal management, medical literature monitoring, database of medicinal products (Article 57) and pharmacovigilance fees, as well as the Periodic Safety Update Report (PSUR) Repository. This further includes an update on new or revised technical guidelines (non-GVP).
- EVWeb is going to be supported for Firefox and Chrome
- By Q3/Q4 2015 Public Access to EVWeb data will be available to the public and HCPs, MAHs and NCAs.
- Electronic Reaction Monitoring Reports (eRMR) will be the format to download case line-listings from the public access in order to help MAHs to fulfill their obligations regarding signal detection procedures.
Article 57 and how data can be used for PhV:
- Before 30 June 2015, all medicinal product data in xEVMPD has to be updated, as it will be used for:
- Calculation of MAH?s chargeable units for PhV fees
- Reporting adverse reactions
- PSUR repository
- Medical Literature Monitoring services (MLM)
- In a near future, changes in QPPV contact details and PSMF location are going to be communicated via Art. 57 and a variation procedure will not be necessary.
- EMA is starting to send advice notices with the information being used for calculation of fees.
- Before 30 June 2015 MAHs are expected to correct all data in Art.57.
- From 1st July 2015 EMA will start invoicing all chargeable units.
- Legal basis and SME status are crucial data to get a fee reduction.
EMA Service of Medical Literature Monitoring (MLM) for reports of suspected adverse reactions:
- In August 2015 MLM service is expected to be launched on production.
- Webtrader users do not have to do any change in their profile
- Gateway users will have to perform testing both in test and production environment.
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: This guidance assists companies in demonstrating that a proposed product is indeed biosimilar to an existing biologic product, and is intended to provide clarity to manufacturers about the expectations for a biosimilar development program.
- Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product. This guidance focuses on the analytical studies that demonstrate that the product is “highly similar? to an existing biological product, which supports the demonstration of biosimilarity.
- Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. A third guidance answers common questions about the biosimilar development and application process and contains information intended to provide a better understanding of the law that allows biosimilar development.
- Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. Draft guidance which is open for receiving comments from the public, answers a variety of additional questions that have arisen regarding the biosimilar development process.
The key changes resulting from this new system will be:
- After 1st October, for Marketing Authorisation Applications and variation applications, advance payment will no longer be accepted
- Annual fees for marketing authorisations will be sent to customers every year, approximately two months before the marketing authorisation grant date.
- MAHs are asked to provide FIMEA with an invoicing address (only one), to which all invoices will be sent (MAAs, variation applications, annual fees, licence and inspection fees), before the 15th of June.
During the webinar our Regulatory Information Director, Remco Munnik, will provide you an update on the implementation of the eSubmission Roadmap with special focus on eCTD, eAF and Common Repository. After the theoretical part, Oliver Bosch (Application Support Specialist) will give you an overview how to create a Submission within EXTEDO´s eCTDmanager.
AsphaTeam: ASPHALION is happy to announce the new position of Ana Duarte as Business Development Officer.
(Remco Munnik as speaker)Munich, DE