New in Departments

Perspective | 1 April 2014
Elisabeth Kübler-Ross identified the five stages of grief as denial, anger, bargaining, depression and acceptance. Regulatory submissions are really no different. Read more »
Perspective | 28 March 2014
Baseball: America's favorite past time, and strikingly similar to the world of pharmaceutical advertising and promotion. Read more »
Under RAPS | 10 April 2014

RAPS announces the establishment of a new chapter in Taiwan, its first in Asia.

Read more »
Under RAPS | 9 April 2014
RAPS is seeking applicants who want to make a difference in the regulatory profession as members of the 2014 Class of RAPS Fellows. Read more »

Regulatory Update

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Brazil’s national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to review devices as soon as its foreign manufacturing Read more »

The European Medicines Agency (EMA) announced on 8 April 2014 that it plans to launch a final round of meetings in May with organizations representing patients, academia, the pharmaceutical industry Read more »

Health Canada issued revised product monograph guidance on 4 April 2014 that sets forth new design and format requirements, and also includes a new section on preparing patient information. According Read more »

On 31 March 2014, the China Food and Drug Administration (CFDA) and China's State Council Legislative Affairs Office announced the first major overhaul of the regulations governing medical devices Read more »

Regulatory Exchange

Join the discussion -- RAPS Regulatory Exchange

RE:Regulatory Assessment in Change Control -
Posted: 4/17/2014 12:15:24 PM
From : Discussion Post>>Regulatory Open Forum
Can't help but wonder how many people here also find this surprising, and how many find it sadly predictable. ------------------------------------------- Julie Omohundro RAC Durham NC United States -----------------------------...

Risk-Based Biocompatiblity Assessment Timeframes?
Posted: 4/17/2014 12:09:27 PM
From : Discussion Post>>Regulatory Open Forum
If you have experience with ISO 10993 risk-based biocompatiblity assessment with new devices, I would like to know about how long it takes to get from the date on which you devices available for testing to the date you have completed ...

Forecasting in Regulatory Submission
Posted: 4/17/2014 10:46:49 AM
From : Discussion Post>>Regulatory Open Forum
Hi, Pelase share any URL where I can refer the topic - Forecasting Regulatory Submissions for 1) Global Markets (USA, EU & Japan) and 2) Pharmerging nations (BRICS+ Low Regulated Markets) Thanks, Ab...

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