EMA's Policy On Proactive Publication Of Clinical Data: First Reports To Be Made Public In Mid-Sept
This article was originally published in SRA
The European Medicines Agency's policy on proactive publication of clinical trial data from drug applications submitted for approval after January 2015 is expected to result in the first clinical study reports being made public in mid-September. The EMA was earlier aiming to publish the clinical study reports under the policy from mid-20161.
The delay in the publication of the clinical study reports has been on account of the long time it took the EMA to finalize one of the three guidelines that are critical to help the pharmaceutical industry comply with the requirements of the policy, EMA's chief policy advisor Noël Wathion told Scrip Regulatory Affairs on the sidelines of a conference in London organized by the European Generic and Biosimilar Medicines Association on 27-28 Jan*.
"The last bit that we had to finalize was a consultation [on a procedural guideline] with the pharmaceutical industry on how to submit the [clinical study] data [under the policy]… We had some meetings and further discussions with them, which continued over the New Year so that held up everything," Wathion said.
He explained that all three guidelines2 – the first, on how companies should identify and redact commercially confidential information from clinical reports; the second, on anonymization of personal data in clinical reports; and the third, on procedural aspects involved with submitting clinical reports for publication – have now been finalized and will be published in mid-February.
The EMA will now have to undertake a number of IT-related tasks to support the publication process. Also, it will liaise with individual companies as clinical trial data from their marketing authorization applications are prepared for publication to clarify aspects of commercial confidentiality. As such, Wathion believes that the EMA "will be on a learning curve" as it puts the policy into practice.
The EMA's policy on publishing clinical trial data was adopted by the agency's management board in October 20143. It applies to new marketing authorization applications and Article 58 applications submitted under the EU centralized procedure after Jan. 1, 2015.
Under the policy, nearly all clinical trial data in marketing authorization applications – except for information that is commercially confidential or which affects patient confidentiality – are to be made available to the public. For applications relating to extension of indications and line extensions for existing centrally authorized products, the policy will apply to submissions made after July 1, 2015.
The EMA will publish the clinical study reports only after the marketing authorization procedure is finalized at the EU level, i.e., following the European Commission's decision to grant or refuse marketing authorization/extension of indication/line extension or following receipt of a letter from the company notifying the withdrawal of the application.
With regard to the second phase of the policy, under which the EMA intends to publish individual patient level data (in addition to the clinical study reports), Wathion said that there may be an internal discussion on this at the agency later this year.
* EMA's chief policy advisor Noël Wathion gave a presentation on "Looking to the future – EU Medicines Agencies Network Strategy to 2020 – EMA deliverables" at the 15th EGA Regulatory and Scientific Affairs Conference in London on Jan. 28, 2016.
References
1. The do's and don'ts for drug makers under EMA trial data publication policy, Scrip Regulatory Affairs, July 1, 2015
2. EMA Guidance On Redacting Commercially Confidential Info In Clinical Reports Nears, Scrip Regulatory Affairs, Sept. 21, 2015
3. Wait over for landmark EMA policy on trial data access, Scrip Regulatory Affairs, Oct. 3, 2014