Patricia Santos-Serrão
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There are no holidays or time off when it comes to complying with regulations. Companies need to be ready to meet the latest
standards at all times. With that in mind, new USFood and Drug Administration programs are sure to keep pharmaceutical companies
of all sizes busy in the year ahead. Here's how to get through.
Electronic common technical documents
The deadline for the much discussed , mandatory electronic Common Technical Docment (eCTD), has already arrived—January 1,
2008—andFDA's Center for Drug Evaluation and Research (CDER) now expects all investigational new drug and marketing applications
to be submitted in electronic format. Companies unable to meet eCTD requirements don't have too many options. They can, a)
resort to submitting applications in paper CTD format, using "temporary hardship" as an excuse, or b) outsource the work.
Both solutions carry the possibility of delay, distraction, increased costs, and diminished prospects for success.
The more practical—and longterm— solution is to implement an eCTD publishing system in-house. Companies pursuing this option
should seek to gain more than just eCTD compatible output. Getting an eCTD ready goes beyond the ability to produce PDF files
with the appropriate hierarchy and XML backbone for navigation. The life cycle management of the product as a whole is critical
in managing changes and requests for information from global agencies. Document management and document changes are also tied
to product registrations and submission life cycles. An integrated solution is ideal for managing the document, submission,
and product life cycles on an international level and should include the following information:
- Which products, formulations, dosages, dosage forms, and indications are currently approved in the target country(ies)?
- Which applications are affected if information (e.g., request for clarification, updates) is changed?
- How will a change in information affect non-US applications?
- What are the license renewal dates and actions that must be taken for product management worldwide?
Product strategy
The development of a global regulatory strategy document (GRSD) should be on top of a company's "to do list" in 2008. This
document provides a gameplan for regulatory strategy to achieve a company's objectives in marketing and supporting a drug.
The GRSD include information such as:
- Product's indication, intended use, and target population
- Product classification as defined by the regulatory agency (varies from country to country)
- Partners involved in the product (e.g., clinical research or manufacturer organizations, consultants, submission outsourcing
partners, sales-marketing partners)
- Product registration strategy
- Order of application filings (e.g., which countries and when)
- Country specific requirements (e.g., renewals)
- Submission timelines
- Short- and long-term regulatory objectives
- Prescription versus over-the-counter designation
- Manufacturing strategy.
There are no guidelines or regulations that explain how a regulatory strategy should be compiled. However, several industry
organizations have resources and conferences that outline what should be included for pharmaceuticals and biologics in a regulatory
strategy.
RiskMAPs
Companies should also develop a risk minimization action plan (RiskMAP) either as part of a more diverse GRSD or as a separate
initiative to meet current regulatory guidelines. A RiskMAP includes both risk assessment and risk minimization. A RiskMAP
strategy should be multidimensional and address various methods of minimizing risk, including how to reduce and control potential
drug misuse, abuse, or overall risk based on the target population's demographics and contraindications. Specifically, a RiskMAP
strategy should outline the following and provide the corresonding benefits:
- Ensure appropriate drug labeling (e.g., black box warnings)
- Enable responsible product promotion
- Provide distribution controls for highly addictive products
- Demonstrate active pharmacovigilance
- Provide appropriate education of healthcare professionals, patients, and sales personnel.
