NeeS: A Thing of the Past
Apr10

NeeS: A Thing of the Past

With 2018 well underway, if you’re still not submitting in electronic Common Technical Document (eCTD) format in Europe, now is the time to transition. Non-eCTD electronic Submission or “NeeS” have been accepted for many years. However, they are becoming less common for National Procedures. Furthermore, at the end of this year, NeeS will be a thing of the past.  On 10 March 2017, the European Heads of Medicines Agenices (HMA) announced that eCTD will be mandatory for all regulatory activities in National Procedures as of January 1, 2019.

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EMA Reasons for Rejection of CCI
Mar27

EMA Reasons for Rejection of CCI

New data from European Medicines Agency (EMA) confirms the tough position EMA is taking in regard to commercially confidential information (CCI). According to the European Medicines Agency’s “EMA Update on Clinical Data Publication” published on 29 January, 2018, 76% of CCI instances were rejected in 2017. Interestingly, the EMA has provided further insight on how they are considering CCI by citing five reasons for rejection.

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Avoiding Policy 0070 Pitfalls and Ensuring Compliance
Dec21

Avoiding Policy 0070 Pitfalls and Ensuring Compliance

The European Medicines Agency (EMA) Policy 0070 guidance was initially issued in 2016 and since then has undergone several iterations. The evolving guidance adds complexities to the Marketing Authorisation Application submission process, challenging organizations to be agile with their teams and processes as they establish best practices and stay current with policy changes. Although Policy 0070 continues to be expanded for openness...

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Expectations for the Implementation of eCTD v4
Sep27

Expectations for the Implementation of eCTD v4

On December 15, 2015, the International Conference on Harmonization (ICH) endorsed Step 4 of the eCTD v4.0 Implementation Package v1.0. Step 4 signals that major stakeholders agree on guidance. ICH released its implementation guide in early April 2016 and regulators in the US and EU followed suit. Industry is taking very real steps to implement eCTD v4. I’ve compiled a list of expectations on timing and impact for eCTD v4.

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What You Need to Know about Europe’s eCTD Module 1 v3.0 Specification
Feb18

What You Need to Know about Europe’s eCTD Module 1 v3.0 Specification

Many international regulatory affairs professionals have come to dread the phrase “Module 1 Change” in the past decade. What looks like a simple reshuffling of leaf titles or the addition of a few new submission types grows into a much more complex problem to solve. Those of you in regulatory operations see on thing in large red letters – VALIDATION. The European Union is taking its turn in 2016. The EU M1 v3.0 final specification was published in October 2015 and is set to take effect July 1, 2016. The specifications become mandatory on October 1, 2016.

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