Throwback 2016
Regulatory Guidelines for the Pharma Industry, so far in ‘16
In an ever changing world of Life Sciences regulations, the Pharma industry has seen many new mandatory requirements from the health authorities worldwide.
In an ever changing world of Life Sciences regulations, the Pharma industry has seen many new mandatory requirements from the health authorities worldwide.
Are you planning for clinical or non-clinical studies post December 17, 2016? If yes, we suggest you take a look at Food and Drug Administration’s (FDA’s) study Data standards applicable for certain types of submissions to CDER and CBER.
In the October released guidance, Medicines Control Council (MCC) has given clarity for manufacturers who are willing to submit applications for medicine registrations in electronic common technical document (eCTD) format. The guidance mainly emphasized the implementation timelines of South African Module 1 eCTD Specification and Validation Criteria v2.0.
When it comes to dossier submissions for medicine registrations, each country has its own Regulatory data requirements which should be submitted in set formats and templates. Likewise, dossier submissions towards South African market has specific format to be considered. Regulating complementary medicines in South Africa post June 2016 requires dossier submissions in ZA CTD (South Africa Common Technical Document) format.
As per the United States Food and Drug Administration (USFDA) and Health Canada norms, adopting technology, its processing, managing, labeling, and details of any label changes made, including changing the content of the formatted label and the carton labeling or container labeling, have to be electronically submitted using the Structured Product Labeling (SPL) and Structure Product Monogram (SPM).
Structured Product Label
The Regulated Product Submission (RPS) is an HL7 standard introduced by the US Food and Drug Administration (FDA). As defined in the Prescription Drug User Fee Act (PDUFA), the Regulated Product Submission helps Life Sciences companies submit product information to Regulatory Authorities in a streamlined manner. The Regulated Product Submission HL7(RPS) standard is intended for broader use as compared to an electronic Common Technical Document (eCTD).
Ever evolving Regulatory landscape, healthcare system reforms, and on-going technological advancements: with these factors influencing regulatory procedures at the most, the biggest task for life sciences organizations is to reduce the operational costs while managing the procedural efficiency for end-to-end compliance. The involved costs, per say, could be of the Regulatory workforce, facilities, and other hidden operational burdens.
Do you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017.
With an aim to grab the maximum market share, drug manufacturers (innovators/generics) may sometimes wish to market their products, across the globe, which have already got approvals in one region. However, following a single regulatory approach for all the regions is almost a difficult task and perhaps not advisable. Therefore, the need of the hour is to implement a highly scalable and flexible submission solution that harmonizes the documents to be submitted in targeted countries.
Organizations shall submit Active Substance Master Files (ASMF) to get complied with the regulatory authorities on Chemistry, Manufacturing, and Controls of a drug substance. While approaching for ASMF submissions, major challenges organizations face includes managing various ASMF submission formats either NeeS or eCTD and if companies have approved ASMFs already, converting them to electronic formats basing on the region-specific requirements.