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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:Generic submission in Japan
Posted: 4/24/2014 6:19:23 AM
From : Discussion Post>>Regulatory Open Forum
Generic application cannot be submitted while the new drug is under re-examination period in Japan even if the patent of the new drug is expired. ------------------------------------------- Toru Murakumo RAC General Manager, Regul...

Multifunction medical device which is OTC and Rx
Posted: 4/24/2014 3:06:08 AM
From : Discussion Post>>Regulatory Open Forum
Does anyone know of a device with several medical functions (by way of example only: ECG, Heart Rate, Blood Glucose, Pulse Oximetry), where some of the functions are OTC and some are prescription, and the FDA has cleared the device vi...

RE:Timing of Self-identification and GDUFA Fees
Posted: 4/23/2014 5:25:29 PM
From : Discussion Post>>Regulatory Open Forum
Charles, Not sure I understood your question. Is the new generic drug you are preparing to manufacture an FDA approved drug for commercial distribution? If you answer is yes, then you will need to identify as a generic manufacturer ...

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