Introduction
Employing the right enterprise resource planning (ERP) system can help pharmaceutical companies gain regulatory approval of drugs and other new products faster and with fewer requests for missing information.
“One of the benefits of enterprise management systems is that much of the data these regulations require can be collected through automated means. Thus, enterprise systems can be used to ensure compliance with increasingly onerous federal regulations without taking personnel away from their essential customer service functions,” the University of Scranton states.
Other advantages of an ERP system include:
- Real-time data access
- Standardizing business processes
- Secure data
- Usable and shareable data
The FDA Approval Process
The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is the agency responsible for ensuring new drugs follow the regulatory approval process. CDER does not test drugs but its Office of Testing and Research performs limited drug quality, safety and effectiveness research.
CDER physicians, chemists, pharmacologists, statisticians and others review every piece of new drug application (NDA) data. This includes labeling, which follows specific FDA formatting and requirements.
The FDA currently has 12 approval steps that follow preliminary drug development. ERPs are designed to ensure pharmaceutical companies keep accurate track of every step from the purchase of raw materials to the labeling of individual samples.
Figure: 1FDA’s Lengthy Drug Approval Process in Twelve Steps
Gaining FDA Approval
Pharmaceutical manufacturers can easily invest years and years, and vast amounts of money developing a new drug therapy.
The regulatory approval process itself can take 6 to 10 months depending on how many benefits the medication provides. Changes to the FDA Standard Review process in 2002 defined a 10-month goal to look at drugs offering minor improvements over existing marketed therapies.
The FDA also offers Priority Reviews with the goal of completing them in six months. These reviews are applied to drugs offering treatments where none currently exist. Priority Reviews are also given to medications that offer major advancements in treatment.
Using the most recent update to the Prescription Drug User Fee Act (PDUFA)—the sixth version—the FDA uses collected fees to hire more reviewers and support staff.
These fees are not cheap. In fact, according to the FDA, the 2021 application fee with required clinical data is $2,875,842, a change of -2.3% over 2020 ($2,942,965). The FDA can also issue additional invoices for program fees not previously invoiced.
| User Fee | 2020 | 2021 | Change |
|---|---|---|---|
| Application Fee: Clinical Data Required | $2,942,965 | $2,875,842 | -2.3% |
| Application Fee: No Clinical Data Required | $1,471,483 | $1,437,921 | -2.3% |
| Program Fee | $325,424 | $336,432 | +3.07% |
| Source: FDA | |||
Regulatory Audits
The FDA inspects and assesses regulated facilities during a regulatory audit. Some of the audit information is released to improve the public’s understanding of how the agency protects public health, its website states.
According to the FDA, “Disclosure of a firm’s inspection information encourages firm compliance and provides the public with an understanding of the Agency’s enforcement actions and an ability to make more informed marketplace decisions… Laboratory records and logs represent a vital source of information that allows a complete overview of the technical ability of the staff and of overall quality control procedures.”
The FDA has 10 detailed inspection guides related to drugs alone. For example, the guide for pharmaceutical quality control labs has 21 sections, which includes laboratory management.
The Role of ERP Systems in Regulatory Compliance
The Microsoft Dynamics 365 ERP platform seamlessly gathers data from different teams and stores it on Microsoft Cloud Servers. Researchers can review records during the development phase. Easy access to earlier successes and failures ensures work is not duplicated, increasing efficiency. Microsoft 365 has the ability to let information technology (IT) administrators apply labels to different documents. These labels let companies classify and protect sensitive data—like formulas—allowing access only to qualified, approved users. Sensitivity labels also apply content markings that can encrypt data, preventing it from being viewed by competitors and outside sources. Pharmaceutical companies can control who is able to view this data and for how long.
Regulators are allowed to see only the data they need, not private, confidential materials.
During the Investigational New Drug (IND) phase, the sponsor submits an application containing the drug’s composition and manufacturing and an outline of the human trials. Among the documents being reviewed in this stage are those related to informed consent and human subject protection.
The ERP Regulatory Advantage
ERP software has several advantages over using spreadsheets and external databases when dealing with regulatory compliance.
A key element is tracking the supply chain from ordering raw materials to delivering finished products to customers. Microsoft Dynamics 365 Supply Chain Management is an example of an ERP product that uses a single, secure, cloud-based database to eliminate duplicate spreadsheet entries and transposed numbers. Additional key compliance benefits of using the right ERP include:
- Visibility and transparency: ERPs have lot and serial number traceability, tracking material flow. This is a common compliance requirement.
- Audit trails: This is included in D365, allowing administrators to know who accessed the system and when, what actions—including file deletions—were taken and where updates originated. Auditing can be enabled or disabled for an entity or specific fields within an entity.
- Data access and security controls: these are built into Dynamics 365 products as mentioned earlier.
- Encryption: Transactional data is securely stored and automatically encrypted when accessed by authorized individuals.
- Electronic signatures: Secures transactions by confirming the operator is authorized while also creating a transaction summary and log.
- Record Retention: D365 allows this to be set through the Privacy settings and elsewhere. For example, D365 Finance automatically saves attached documents for 180 days. That number can be adjusted through the document management parameters > General > History > Enable document history settings
- Inspection Controls: D365 allows companies to store and track test evidence, ensuring materials meet quality control standards.
- Document Controls: Tracks and manages formulas, engineering specifications, material specifications, operating procedures and other document types.
Summary
Getting a drug approved by the FDA is a time-consuming, expensive proposition. The cost of regulatory approval for pharmaceutical products can easily exceed $3 million in government fees alone.
The right ERP can help companies track materials throughout the supply chain and product development. This enhanced tracking and secure data storage reduces the efforts required to navigate the drug approval process.
Book a assessment to learn how an optimized ERP system ensures regulatory approval.
