;   Medical Translation Insight: Counting down to new EMA pharmacovigilance legislation - ForeignExchange Translations

Counting down to new EMA pharmacovigilance legislationFor most of us, it's simply a mouthful: pharmacovigilance.

But for drug manufacturers, it is critically important to collect, monitor, research, assessing, and evaluate information from healthcare providers and patients on the adverse effects of medications. So, pharmaceutical and biotech companies are paying close attention to EMA's looming new pharmacovigilance legislation.

Major changes to the legislation covering pharmacovigilance in the European Union (EU) were announced on December 31, 2010. This is the biggest change to the regulation of human medicines since 1995 and will have significant implications for drug safety. The new laws will apply from July 2012 and have three broad objectives:

  1. to strengthen post-authorisation regulation of medicines,
  2. to improve efficiency, and
  3. to increase transparency.
EMA is making sure to communicate progress regularly. Just last week, we saw a news release entitled "Better protection of public health: European Medicines Agency counts down to introduction of new pharmacovigilance legislation". It was accompanied by a detailedplan for implementation [PDF link].

Agencies and biopharmaceutical companies, start your engines; July 2, 2012 is just around the corner!

[Tip of the hat to Kathie Clark!]

To find out more about this topic, take a look at the following:
ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.

1 Comment:

  1. Christopher Hatton said...
    The question is, how many companies have already started completing the forms containing the pharmaceutical composition and manufacturing details?

    Some of the information is easy to complete, and most companies should have most of this information to hand, however discussions we had in November and December last year suggested this was not going to be so easy getting the actual regulatory, quality, PV and manufacturing details together.

    However the plus side is that for some firms, it has meant that they needed to do some regulatory compliance checks and realised that they must submit some regulatory compliance variation to their marketing authorisations.

    It will be fascinating to see if in the future we/EMA can monitor certain excipients or for example see if low cost sourced API are linked to increased adverse events.

    [Via LinkedIn]

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