Regulatory News

Translation by Google:

The AGES PharmMed now accepts the purely electronic submissions for human use without additional paper copy, except for those documents that need to be signed: Company letter and application form.

By the AGES PharmMed is strongly recommended that correspond to the eCTD electronic submissions or Nees standard. In this connection it is pointed out that the eCTD is the preferred standard, and it is the default Nees is only a temporary solution.

The electronic filing is in the AGES PharmMed currently not mandatory, it will continue to accept submission in paper form.

Read more: AGES PharmMed

In this issue:

• Pharmacovigilance of vaccines against pandemic influenza (H1N1) 2009 in Switzerland
• Venous thromboembolism among oral contraceptive
• SSRIs - risks in newborns more info

Read Vigilance News

The European Medicines Agency has today unveiled a package of changes that will allow it to manage its core operational tasks more efficiently and improve the quality and consistency of its communications with its partners and the public.

- New organisational structure
- New visual identity
- New website and e-mail addresses

Please note that this website and some of the documents published on it will continue to bear the Agency's old logo during a transition period expect to last until early 2010, when a new public website will be launched.

A press release is available here

In version 1.0 some minor errors detected in version 1.0 have been corrected. Both versions v1.0 and v1.0.1 are equivalent. eCTD submissions will be accepted by Swissmedic as of January 1, 2010 if they comply with either v1.0 or v1.0.1 of the Swiss Module 1 Specification for eCTD.

Read more: Swissmedic

The [Swiss] government has asked Swissmedic, the Swiss regulatory body, to start negotiations with the European Medicines Agency (EMEA) in order to give it access to the EMEA's confidential data, the minister, Didier Burkhalter, told journalists on Friday.

Read more: swissinfo.ch

The new EU health commissioner, John Dalli from Malta, will now be responsible for the European Medicines Agency, as well as being in charge of the biotechnology, pesticides and health unit, which moves from the Commission's environment section.

Read more: Euractiv

The Danish Medicines Agency have issued a reminder with respect to the EMEA's community database EudraGMP:

Please note that the Danish Medicines Agency will still be issuing paper MIAs (manufacturing and import authorisations) and GMP certificates, which will be submitted by ordinary mail. In addition, the EudraGMP database will not replace the use of free sales certificates.

Read more at the Danish Medicines Agency

The European Medicines Agency have issued a communication. The following is an extract:

While you may be familiar with us as ‘the EMEA’, many of our partners and stakeholders over the years have told us they find the acronym confusing, firstly because it does not accurately reflect our name ("What does the second 'e' stand for?") and secondly because it is an acronym widely used in the business community to mean ‘Europe, Middle East and Africa’, which can cause some confusion.

Since it is important to us that we communicate clear and unambiguous messages about who we are, we have decided that we will no longer be using the EMEA acronym in our communications, and it does not feature in our new logo.

Please note that we will not be calling ourselves ‘the EMA’ either. Although this may seem a more obvious acronym, it is not one that feels right for us yet. We may reconsider our position at a later stage, if ‘EMA’ evolves naturally into a commonly accepted and widely used shorthand for our organisation. Until then, however, we will be using only our full name (or 'the Agency', for short) in our communications.

The changes will be reflected in all aspects of the Agency's business and will include a new logo and web address.

For more information read the the Agency's communication

The Heads of Medicines Agencies have released an update on the readiness of national competent authorities to accept electronic-only submissions.

HMA press release

Since 1 January 2009, the Danish Medicines Agency has accepted electronic-only documentation for applications submitted under the Centralised Procedure (CP), and from 1 January 2010, we will also be accepting electronic-only submissions for initial, variation and renewal marketing authorisation applications submitted under the National Procedure (NP), the Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP). The Danish Medicines Agency will still be accepting submissions based on paper (see below). If the documentation of an application is submitted both in paper and a valid electronic format, the application will be processed as a paper submission.

Read more: Danish Medicines Agency