Almost one-third of Type IA variation notifications are being rejected by Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) due to not meeting the filing criteria or including the right administrative information, according to an assessment by MHRA covering the six months since the new EU variations regulations became effective.
The MHRA review is the first significant assessment of the industry/regulator experience with the new variations regulations, which allow Type IA notifications to take place after the change is made.
The EMA regulations bring the EU closer to the US model. Under the new EU policy, the categories of “minor” variations considered to have little or no impact on product quality and not requiring preclearance are clarified and expanded, and the provision is made for post-approval change management protocols (IPQ May 2010 Report).
The new variations regulations (EC/1234/2008) took effect on January 1, 2010 and apply to variations to marketing authorizations covered by European procedures. However, the MHRA has also applied it to purely national variation filings since then as well.
MHRA explained that it was sharing its experience to date “to help ensure that companies are submitting the new Type IA notifications correctly.”
In support of this effort, MHRA also published the results of an audit of Type IA variations filed during June and an updated “frequently asked questions” (FAQ) on variations submitted under the new regulations.
[More on MHRA’s assessment of variations filings under the new regulations, including common deficiencies and the agency’s advice to marketing authorization holders, as well as links to relevant documents are available to subscribers here.]