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.

Knowledge Management:

• 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

Electronic Submissions:

• 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.

Change Control:

• 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.

Internal Audits:

• 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.

Regulatory Non-Compliance:

• 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
  • Cause
  • Impact
  • 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

Clinical Trials:

•  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

• Exhibit Batch :
  • 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
  • Changes
  • 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
  • Product
  • Facility
  • Technology
  • 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

Alerts:

•  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.

Risk Assessment:

• 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