Regulatory Work Plan
- The Regulatory Work Plan is to direct organizational resources to assure compliance of regulatory activities & the most effective work practices.
- It must include resource allocations to the support of all Product Development activities from early stage development to commercial launch.
- To provide continuous support to Product Development (PD) and all other functions in the organization.
- To Review and guide PD work on all issues of relevance to the Technical and Regulatory Quality of the product under development.
- Metrics should be developed for key regulatory functions and tasks and reported on at least monthly,
- To allow for resource management against the Regulatory Work Plan
- Determination of acceptable business and Regulatory Compliance.
- RA Intelligence shall develop a process for communicating information, which includes
- New or changing regulatory requirements
- Industry information
That may impact Company Products particularly for development projects.
- This level of association will significantly help avoid review issues related to failure to provide data for a product that could be caused by updated/new Agency guidance.
Documents and Records:
- All documents shall be maintained at least electronically and in accordance with any retention schedules defined by Regulatory Policy.
- Regulatory Affairs is to provide continuous support to the Product Development effort on an individual molecule.
- Defines the responsibilities and processes for preparing and maintaining Regulatory documents and records.
- Regulatory Affairs is to review and guide PD work on all issues of relevance to the Technical and Regulatory Quality of the filing
- Where local Regulatory Authorities allow for electronic submissions of regulatory documentation, it is Company’s policy to have in place the means to submit electronically.
- To ensure consistency of practices, standardized procedures shall be established and a training program shall be implemented.
- A formal change control system shall be implemented and supported in accordance with the Quality Policy.
- The procedures should ensure that changes occurring from at least Exhibit Batch onwards are captured.
- To ensure, RA shall review all change controls generated, for assessment of regulatory impact to ensure continued Regulatory compliance
- The procedures should also ensure that implementation of the change by Quality Unit does not occur until all necessary Regulatory Authority approvals are obtained.
- An independent internal audit shall be conducted at each site, to verify that systems (e.g. Adverse Drug Experience Reporting, Annual Reporting) are functioning in a manner that meets regulatory compliance expectations.
- The management of the internal audit shall reside with the Quality Unit, with the frequency and conduct of the audits covered by the same procedures used for other internal audits.
- Any incident that results in non-compliance of a regulation or requirement set by a Regulatory Authority or standard Industry practice shall be documented & investigated as per the approved Quality procedures by Quality Compliance.
- The investigation should be conducted to the extent necessary to determine
- Corrective and preventative action (CAPA)
Annual Reports/Annual Product Reviews/Renewals/Re-Registrations:
- Annual Reports or other periodic aggregate reports, where required by the Regulatory Authority, shall be completed in the format and time-frame required by the regulations or other regulatory requirement.
- A reporting schedule shall be prepared annually by Regulatory/Quality Compliance and maintained to reflect any changes, stating the timing of reports for the coming year.
- Reporting to management on compliance to Annual Reporting requirements should occur at least on a monthly basis and should include data, such as
- Upcoming reports
- Reports filed
- Timing of filing as compared to required file date
- Regulatory Affairs / R&D / QA shall ensure procedures are in place to gain all necessary internal and external approvals prior to the initiation of any animal or human study.
- Reporting to management on upcoming and open studies should occur at least on a monthly basis and should include data pertaining to
- Study recruitment or status
- Any safety concerns
- Timing for start/completion
New Product Introduction:
- Regulatory Compliance shall verify approved procedures are in place to perform final confirmation
- To assure the approval to market the product has been received
- The product meets the registered requirements prior to the initial release to market
- The batch from which the proposed commercial batch manufacture shall be derived and for which documentation is included in a Regulatory Application.
- The Exhibit/Pivotal Batch documentation describes the formulation, the process, equipment and controls that form the basis for manufacture of commercial production batches.
License Renewals :
- License Renewals or the payment of Regulatory Fees, shall occur in the time frame required by the regulations or other regulatory requirement.
- A reporting schedule shall be prepared annually by Regulatory / Drug Enforcement Administration and maintained to reflect any
- Stating the timing of License Renewals OR
- Payment of Regulatory Fees for the coming year
Licensing and Acquisition, Due Diligence:
- Define the requirements and responsibilities of Regulatory Affairs to assure compliance and adequate resourcing are addressed during the process of acquiring a new
- Registration or process
- Completion of QA Assessment Report that includes a risk assessment.
Labeling updates and REMS Program:
- Any Reference-Listed Drug labeling updates as required by Regulatory agency shall be complied to
- All labeling components shall be revised
- Implemented as per Company’s procedures
- New labeling artwork for new products/re-launch will also be developed by Regulatory Affairs as per FDA requirements and guidance.
- Products that are mandated under the Risk Evaluation and Mitigation Strategy (REMS) Program by the FDA shall comply with all REMS requirements.
- Company shall be a part of the single shared REMS System to ensure safe access to and use of the drug by patients.
Adverse Drug Experience Reporting:
- It is Company’s policy to assure that safety-related information is comprehensively and effectively gathered and reported to regulatory authorities.
- This is to facilitate the implementation of labeling and other measures that ensure safest possible use of the product.
- The collection of Adverse Drug Experience Reports or Adverse Device Experience Report is also a regulatory requirement.
- The procedures should ensure that reporting of individual cases and aggregate reports are sent to the Regulatory Authority within the required timeframe.
- A centralized electronic database shall be used to ensure adequate management of the process and compliance with regulations.
- Pharmacovigilance function should be adequately staffed by qualified individuals and new product approvals/product acquisitions evaluated for resource impact.
- Reporting to management on Adverse Drug Experience Reporting activities should occur at least on a monthly basis and should include data, such as
- Volume of ADEs,
- Categorization of ADEs (seriousness and expectedness)
- Compliance of individual and aggregate reporting
- Regulatory Management shall develop and maintain a procedure for assuring that senior management are promptly notified of regulatory compliance events that may affect not only prospective, but also marketed products.
- The Regulatory Department shall be equipped to work with Quality and other Organizations for a comprehensive risk assessment activity as the need arises to support regulatory perspective