EMA Planning Transition To Reviewing Raw Clinical Data
July 14th, 2022 // 10:40 pm @ jmpickett
FDA often talks about the fact that it’s the only global pharma regulator that reviews raw clinical data, meaning the data of individual patients during its pharmaceutical application reviews. This often allows FDA to avoid what could be misleading or biased data offered by a drug sponsor.
This month, the European Medicines Agency (EMA) is considering taking a similar data approach. The human medicines committee or CHMP at the EMA is receiving data from drugmakers after the firm’s statistical work offers the agency its clinical summaries.
CHMP is authorized under current European Union regulations to ask for raw data if the assessment calls for it. But the regulator said that after it does a retrospective review of other regulators’ raw data assessments, there are many benefits to taking a granular approach.
For example, EMA pointed out that using raw data could lead to a reduction of workload for many drug sponsors when there are not as many complex questions. This could lead to a better understanding of clinical study results by the European Medicines Agency, which could reduce the need to ask questions of the company submitting the application.
Starting in September, EMA will begin a two-year pilot program that will evaluate how raw data is used for reviewing 10 drug applications that are turned into EMA.
The regulator said applicants can get in touch with EMA at rawdatapilot@ema.europa.eu to tell of their interest in working in the pilot program.
For drug sponsors who participate in this pilot, the EMA said that results that are helpful for the risk-benefit analysis will be offered in the assessment report and shared with the sponsor as well as the related information about the analysis. Also, applicants will be requested to duplicate the results of the analysis through a list of questions.
