Editorial

Sam Hamilton (author and section editor)

Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161

Clinical Data Publication (Policy 0070) relaunch

Alison McIntosh (author)

In preparation for the relaunch of EMA Clinical Data Publication (Policy 0070), a webinar was held on May 16, 2023, and a video recording of the meeting can be viewed online (https://www.ema.europa.eu/en/events/clinical-data-publication-policy-0070-re-launch-ema-webinar). EMA Policy 0070 relaunch applies to new active substances from September 2023 onwards and includes negative and withdrawn products. Invitation letters will be sent if your product is in scope. Notably, COVID-19 and other public health emergency clinical data publication continues. EMA has confirmed that pre-submission meetings specific to a product can be offered and encourages sponsors to make use of such meetings.

Medical Writing. 2023;32(3):91–92. https://doi.org/10.56012/nnwx9514

Current clinical trial disclosure landscape in Asia

Zuo Yen Lee (author)

The transparency and disclosure landscape in Asia has been rapidly evolving during the past decade. With respect to clinical trial registries, China launched its national registry, ChinaDrugTrials.org.cn, in 2013; South Korea introduced the new clinical trial disclosure platform through its Ministry of Food and Drug Safety (MFDS) in 2019; whilst Japan unified its three existing primary registries into a single clinical trial registry – Japan Registry of Clinical Trials (jRCT) – in 2020. We provide an overview of the national clinical trial registries and the trial results disclosure practices for 4 Asian countries – China, Japan, South Korea, and Taiwan.

Medical Writing. 2023;32(3):96–97. https://doi.org/10.56012/vxbm4667