Newly Revised ISO Standard Will Help Device Manufacturers Address Risk Management

(from RAPS, December 2019)

The International Organization for Standardization (ISO) unveiled its revised standard on the application of risk management to medical devices, giving more attention to the benefits expected from devices, as well other clarifications and additions from the previous version.

The revised standard, known as ISO 14971:2019, replaces the second edition from 2007 and introduces several new definitions on the terms “benefit,” “reasonably foreseeable misuse” and “state of the art.”

Read more here.

EMA Guideline on the Chemistry of Active Substances

Active Substance

Are you preparing submissions to the EMA for marketing authorization this year?  This guideline goes into effect in July 2017 and describes the type of information required for the manufacture and control of active substances used in medicinal products for EMA marketing authorization. It replaces the “Note for guidance on chemistry of new active” (CPMP/QWP/130/96, Rev 1) and “Chemistry of active substances” (3AQ5a) and covers new and existing active substances in one guideline. 

Read more here

FDA Requires Use of eCTD Format and Standardized Study Data in Future Regulatory Submissions

FDA will now require that certain regulatory submissions conform to the electronic Common Technical Document (eCTD) format. In addition, study data will have to be submitted in standardized format for certain studies.  The eCTD has been the standard format for submitting applications, amendments, supplements, and reports to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) since 2008 and makes it easier for FDA to review data, approve new drugs, and monitor drugs after they go on the market. It also simplifies the process for submitters, because the CTD format is used by drug regulatory agencies in many countries.

Starting on May 5, 2017, eCTD will be required for applications submitted to CDER and CBER for the following:

  • New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), and all subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect.
  • Master files, such as Drug Master Files (DMFs), which are considered to be submissions to an IND, NDA, ANDA, or BLA.
  • Combination products (if CDER or CBER is designated as the lead center).

Download the guidance here.

For a complete listing of all documents and supportive files needed in order to submitelectronically, refer to the eCTD Web page at