RI eases getting regulatory summaries from the local regulatory authority.

Most of the large, medium drug companies will function across the globe to address the therapeutic needs of patients. As medicines carry a therapeutic value safety, efficacy and quality outcomes are essential parameters for regulatory assessors and formulators, and to achieve therapeutic goals drug regulatory authorities revise the standards very frequently, staying up to date with ever-changing regulations can be for new, supplement registration, line extension, other vital regulatory commitments like variation, renewal, safety, labeling are always a challenging task for life cycle companies. A strong regulatory intelligence program can help companies to effectively use regulatory data from concerned health authority to make their systems up to date. Most of the times regulatory information is available with local operating partners or affiliates, always there is a gap between corporate office to affiliates in circulating the data and getting info on local standards, therefore it is important to study, place and break down applicable regulatory summary to meet drug authority standards without delay and minimizing the error in the regulatory process. This article describes a program for collecting the data, processing, analyzing, circulating the information with a unified visceral system, such a procedure can cut down time in finding widely disseminated regulatory information, as result derogating errors of the regulatory department.

An extensive source of regulatory information produces a great advantage by providing first-rate insights and auspicates compliance requirements at a local level. The drug companies can make better compliance (responsively) decisions to market their products by predicting regulatory guidance and the requirements. With the objective to formulate a novel product that can be at the same instant filled to several authorities for market clearance, the RA teams functioning from corporate center are required to take initiatives to have definitive filling plan, accurate approach; it should extend over the product life cycle essentially clinical data collection to filling management also collating data and frequently updating the data in a central repository. The companies can utilize spreadsheets or a platform to translate the regulatory data into checklists for each type of submission whether the market clearance for new drug, generic submission or supplement, line extension, safety submission, variations, and product renewal.

Staying up to date in an ever-changing environment

To ensure fillings made simple, responsive, RA teams not only concentrate or aware of local regulations; few other aspects to be ensured from them:

First thing, from 2005, the United States of America (USA), the European Union (EU) and Japan swept up electronic regulatory filing process. The conversion from paper-based practices to electronic transitions where from simple text to common technical document (CTD) formats has become a challenge for regulatory professionals due to electronic publishing.

Secondly, apart from referring or checking to the health authority websites, the drug regulatory authorities also move together with local companies about the practicality and execution of any new guideline, as a result, the pharmaceutical players rely on their locally operating, regulatory consulting companies to get the regulatory information drafted by regulatory agencies.

Majority of drug regulatory agencies are maintaining their websites and keep updated on new initiatives or guidance or policies, draft guidelines to give easy information for drug innovators or formulation companies. The regulatory confederation among the European Union, United States of America and Japan – The International Council for Harmonization (ICH), formerly the International Conference on Harmonious (ICH) - has taken to the standardization of templates for regulatory filings. Even so, it involves expertness and sufficient knowledge to effectively use the data available on the regulatory authority websites which are linking to continuous dependency towards local affiliates or local partners.

Thirdly, some drug authorities like Brazil, Mexico, Poland etc., prefer submissions in the local language, data presentation also varies.

To describe further the main challenge for companies is the frequent changes in the regulatory requirements, knowledge on the revised regulations, regulatory amendments, change rules or procedures highly important as companies aim to get fillings right on the first attempt. Rejection or delay from regulatory authority due to filling errors can directly impact on the product launch also have a direct impact on the revenues.

To minimize or overcome these challenges, larger companies have laid down regulatory intelligence teams to support clinical, market authorization, safety, labelling chemistry, manufacturing and controls divisions. These intelligence teams will refer to the public and authenticated sources and analyse the information provided through the new regulations or guidance’s; though driving business with a small intelligence team is good however it is very difficult to manage or to address as companies that have products multiple product portfolio and multiple regions.

As to enhance the RI team strengths and capabilities, the companies should concentrate to improve the Regulatory Intelligence framework. A strong intelligence framework assures that regulatory data on various requirements are collected, collated and organized on a common repository. Also, data received by local partners or local regulatory consultants from various regions will also be streamlined and refreshed in a central repository, especially with reference to new regulatory requirements.

No discrepancy filings or aiming right on the first attempt

Drug companies focusing on regions like Latin America, Africa, Asia, has a high dependence on local operating and local regulatory consulting partners. As to stay up to date with current regulatory policies the companies are employing local regulatory professionals. The data is normally collected in a weekly manner by HA websites, industry associations, conferences, journals, webinars, other authenticated sources, and utilizing the services from Regulatory intelligence database platforms and in the other half, companies focusing in the USA and EU regions has low dependency on local operating partners as the complete regulatory data easily available from the agencies websites companies are comfortable with regulations. In spite of the fact that dependency on locally operating and local consulting agencies can’t be kept off completely, companies can strength regulatory intelligence operations by looking over the following tips:

Deploy regulatory intelligence portals to enhance research capabilities

Effective periodic training's for data collection, analysis, filtration of frequent regulatory updates

Identifying the right regional information

Analyzing the market, making a fine list of regions where the product has to be launched so that regulatory teams can develop global submission strategies

A few regulatory intelligence reports should be planned well in advance like stability data (differ in various countries) in various temperature zones, submission formats, language requirements, fee etc. by doing these exercises can save time and money.

To conclude, in an ever-changing regulatory environment, the effective regulatory intelligence procedures helps bio-pharma companies effectively concentrate on formulating and introducing new products across the world also by way of continuous monitoring, analyzing regulations with the help of strong regulatory intelligence system or services adds good value in terms taking good decision and bring competitive advantage across the regions.

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