India: Similar biologics guidelines and implementation

Author(s):  
Smita Suneel Singhania ◽  
Krishan Kumar Tripathi

Indian regulatory authorities for biologics, jointly at Department of Biotechnology and Central Drug Standard Control organization in association with the task force comprising Indian biologics manufacturers laid down the regulatory pathway for manufacturing and marketing authorization of similar biologics, claiming to be similar to an already authorized reference biologic. This guidance has come in force from 15 September 2012 in India. This guidance document is a simple abridged process for evaluation of ‘Similar Biologics’ that are approved and marketed either in India, Europe or USA or any other country for more than 4 years.

Author(s):  
Paul C. D. Bank ◽  
Leo H. J. Jacobs ◽  
Sjoerd A. A. van den Berg ◽  
Hanneke W. M. van Deutekom ◽  
Dörte Hamann ◽  
...  

AbstractThe in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.


Author(s):  
Martin Di Blasi ◽  
Zhan Li

Pipeline ruptures have the potential to cause significant economic and environmental impact in a short period of time, therefore it is critical for pipeline operators to be able to promptly detect and respond to them. Public stakeholder expectations are high and an evolving expectation is that the response to such events be automated by initiating an automatic pipeline shutdown upon receipt of rupture alarm. These types of performance expectations are challenging to achieve with conventional, model-based, leak-detection systems (i.e. CPM–RTTMs) as the reliability measured in terms of the false alarm rate is typically too low. The company has actively participated on a pipeline-industry task force chaired by the API Cybernetics committee, focused on the development of best practices in the area of Rupture Recognition and Response. After API’s release of the first version of a Rupture Recognition and Response guidance document in 2014, the company has initiated development of its own internal Rupture Recognition Program (RRP). The RRP considers several rupture recognition approaches simultaneously, ranging from improvements to existing CPM leak detection to the development of new SCADA based rupture detection system (RDS). This paper will provide an overview of a specific approach to rupture detection based on the use of machine learning and pattern recognition techniques applied to SCADA data.


2014 ◽  
Vol 2014 (1) ◽  
pp. 1846-1858
Author(s):  
Martin Cramer ◽  
Bridget O’Farrell-Villareal ◽  
Guy Miller ◽  
Niell Irvin ◽  
Phil Smith ◽  
...  

ABSTRACT In the event of an oil spill, rapid and effective response actions are the key to minimizing impacts to the environment and local communities. Consequently, oil spill response plans (OSRPs) should be prepared in a user friendly format that maximizes access to crucial information and focuses on the critical first few hours or days of a response. While existing OSRPs are generally adequate, they typically are not organized logically and contain fairly general information that focuses on the overall response rather than the initial stages. For many plan holders the primary, or in some cases the only, objective when preparing OSRPs is obtaining regulatory approval and believe there is little latitude in deviating from the format or content of previously approved plans to make them more functional. Following the 2010 Macondo incident in the Gulf of Mexico, the American Petroleum Institute (API) sponsored Joint Industry Task Force (JITF) identified the need to enhance the usefulness of OSRPs. A workgroup was convened consisting of representatives from integrated and independent oil companies and spill response planning consultants to develop a guidance document for preparing OSRPs that are highly functional and regulatory compliant. The JITF guidance document includes a detailed OSRP outline that provides the intended purpose and recommended content and format for each section. The primary features include:Information presented in the general order required when responding to an oil spillFocus is on the first 24 hours when guidance is needed the mostKey information is provided in tabular or graphical formats at the front of each sectionInitial responder health and safety issues are addressed that are often missing in OSRPsSimilar information is located in the same section to avoid searching multiple sectionsMore expansive and detailed information, response guidance and specific cleanup strategies are referenced, as appropriate, in other documents The guidelines were designed to be Gulf of Mexico centric with the concepts being applicable to all industry sectors and regions of the world. Similar to the Integrated Contingency Plan concept developed in 1996, they can be adapted to comply with multiple oil spill planning regulations. They were, however, designed specifically to comply with the Bureau of Safety and Environmental Enforcement (BSEE) 30 Code of Federal Regulations (CFR) Part 254 and Notice to Lessees NTL 2012-N06. The draft guidelines were reviewed and well received by BSEE and the few regulatory compliance issues they identified were addressed in the final document. Therefore, it is possible to prepare OSRPs that are both functional and regulatory compliant.


2020 ◽  
Vol 55 (6) ◽  
pp. 392-398
Author(s):  
Oliver Read ◽  
Stefan Schäfer

AbstractGovernments, regulatory authorities and standard-setting bodies started acting on global stablecoins triggered by the Libra announcement. Among the concerns expressed by the G7 and the G20 are risks to the stability of the financial system. The Financial Stability Board and the Financial Action Task Force have worked on regulatory issues and anti-money laundering ahead of the G20 summit in November 2020. Overall the Libra project has raised many questions on the regulatory front. Facebook had to revise the concept as Libra 2.0 and resubmit it for approval in April 2020. The European Commission announced a new regulation on Markets in Crypto-assets (MiCA) including stablecoins in September 2020 as part of a new Digital Finance Package. This opens the next chapter in a regulatory cat and mouse game.


Author(s):  
Shivali Rahi ◽  
Ajay Kumar ◽  
Arpana Rana

Considering the new Coronavirus pandemic, the interest for antimicrobial products, for example, sanitizers and hand sanitizers are soaring. Regulatory authorities are performing their function by giving approvals to hand sanitizers in various countries through various regulations and marketing authorization procedures. The point of this article is to help in understanding the administrative prerequisites expected to bring the hand sanitizers or sanitizer items into various business sectors, just as the current administrative exceptions and interval gauges set up to help react to COVID-19.


2000 ◽  
Vol 64 (10) ◽  
pp. 708-714
Author(s):  
PJ Ferrillo ◽  
KB Chance ◽  
RI Garcia ◽  
WE Kerschbaum ◽  
JJ Koelbl ◽  
...  

2001 ◽  
Vol 11 (3) ◽  
pp. 6-13
Author(s):  
Lisa Scott-Trautman ◽  
Kristin A. Chmela
Keyword(s):  

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