Dossier Format Requirements in Emerging Markets

By Brooke Casselberry, Senior Manager – Regulatory Affairs

In the past, when Regulatory Affairs departments considered product registration strategies, countries outside of the United States, European Union, Japan and Canada would generally fall under a broad umbrella term called “Rest of World” or ROW.  It was not uncommon to manage information related to supporting dossiers, commitments, and tasks under this broad title.  Sponsors often maintained in-country representatives in each of the ROW countries to manage agency communication, regulatory changes, and dossier updates although keeping abreast of the current status proved difficult for headquarters.  To help companies manage the dossier preparation, many developed core sets of information that would be sent to affiliates to repurpose for ROW registrations. In addition, health authorizes in many of the ROW countries were content to accept product approval decisions made by agencies such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) without requiring a full product dossier review prior to approval.  

However, along with the technology boom, sharing of information among regulatory authorities has become easier. Health authorities are establishing cooperative agreements and other mechanisms to more easily share information and ease some of the burden of review of the registration information.    A major catalyst for this change is the Common Technical Document (CTD).  In 1999, the International Conference of Harmonisation on Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) began developing the CTD to provide a common format to submit registration dossiers to multiple regions.  This mechanism provided industry with a common structure for submitting registration information for pharmaceuticals in the European Union, United States, and Japan.  Ideally sponsors were able to provide most of the same information in modules 2-5 to all accepting regions, with only Module 1 being region specific. Other countries, who had been observers to the ICH process, also began accepting applications in CTD format.  Today, many more regions have begun accepting CTDs.  As a result, the term “Rest of World” has essentially become extinct and a new definition has been created, “Emerging Markets”.

In 2003, ICH started the electronic Common Technical Document (eCTD) initiative in an attempt to realize some of the benefits that the US FDA had seen in regards to receiving registration information electronically.    The eCTD provides a mechanism to transfer, review, and maintain registration information electronically.  The implementation of the CTD and eCTD proved to be of benefit to both sponsors and regulators resulting in higher quality dossiers and efficiencies in the review processes.  A mid transition between the CTD and eCTD is Non-eCTD Electronic Submission (NeES).  NeES submissions are in the CTD format, provided electronically, however they do not contain an XML back bone.  Here is a Dossier Comparison Table detailing what many Emerging Markets are currently accepting:

EMERGING MARKETS DOSSIER COMPARISON

Country	CTD	eCTD	NeES
ASEANhttp://www.aseansec.org/	ACTD  (Fully Implemented June 2011)	No	Malaysia and Singapore Only
Australiahttp://tga.gov.au/	Yes	In process of implementation	Yes, January 2011
Chinahttp://eng.sfda.gov.cn	Yes (Limited implementation)	No	No
Croatiahttp://www.almp.hr	Yes	Yes	Yes
Indiahttp://cdsco.nic.in/	In process of implementation (2010)	No	No
South Africahttp://mccza.com/	Yes (June 1, 2011)	No (Postponed until further notice)	Yes
Saudi Arabiahttp://www.sfda.gov.sa	Yes	Yes
Turkeyhttp://www.iegm.gov.tr	Yes	No	Yes

 

*Information in this table is current as of September 30, 2012.

The Emerging Markets arena is changing with dramatic speed, and in some cases almost overnight.  As we continue to monitor globally for additional Emerging Markets making their way into the CTD spotlight, we find opportunities for product placement, new initiatives and increased safety for consumers.  In order to stay current, it is necessary to closely monitor these regions as changes continue to be implemented.