Drug review and approval are the essential functions of a drug regulatory authority. The pharmaceutical industry of a particular market or country depends on the efficient working of drug regulations. It reviews drugs' properties, efficiency, safety, and efficacy against accepted rules and regulations. Depending upon the comparison results, it then allows or disallows a pharma manufacturer to produce that drug in its area of control.
There are various functions and departments that a regulatory authority reviews, such as personal expertise, documentation, equipment, manufacturing facilities, utilities, and other relevant requirements to make its decision. If it finds out that the drug manufacturer has made adequate arrangements for safe and efficient drug manufacturing, the drug regulatory authority permits to production and market of the drug. Otherwise, the pharma manufacturer cannot produce a pharma drug until it completes all the regulatory body requirements.
Why Drug regulatory authority updates their Rules and Regulations
Pharmaceutical regulatory authorities regularly update their rules and regulations regarding drug review and approval. Because pharma industry is constantly evolving, and there are new challenges every time a new dimension is achieved. The changes in the regulatory requirement for drug review and approval cannot be abrupt but requires proper justification and acceptance criteria.
Some ways a regulatory body forms a justification are mentioned below.
Regulatory bodies keep an eye on the research conducted by various pharma manufacturing companies. And in some cases, it becomes part of that research. The main reason is to keep itself updated on the latest technological advancement in pharmaceutical drug development and manufacturing. It focuses on areas such as new diseases, the impact of existing technology, or other related factors.
If a regulatory body finds that existing rules and regulations are enough to cope with the present-day challenges, the regulatory body keeps its existing rules unchanged. On the other hand, if it finds out that drug review and approval rules are outdated and fails to fulfill present-day challenges, it tries to update its rules and regulations.
The global pandemic plays a critical role in reviewing and approving drug regulations. The widespread global pandemic indicates a significant loophole in drug manufacturing and Research companies' ability to fight against the disease. It also indicates weaknesses in pharma organizations' structure, ability, system, research, and expertise. The first step in preparing pharm manufacturing to produce drugs for pandemic, is to develop guidelines that can become effective during a pandemic.
Regulatory bodies keep an eye on the global pandemic to review their guidelines. If pharma companies, following the regulations and guidelines, can tackle and fight the global pandemic, it is assumed regulatory bodies' guidelines are up to date and do not need amendment. If not, these guidelines require more research, clinical trials, investment, and review.
Market recalls referring to the activity where a specific product or batch is called back from the market. This becomes inevitable due to complaints received due to negative feedback from the product user or unusual side effects.
The product effectiveness studies during the clinical trials phase are integral to the drug approval procedure. They are conducted to prevent these side effects, impacts, and recalls.
Product recalls can be due to negligence in implementing quality practices and failure to ensure safety systems. This result in out-of-specification product properties of a product that deviates from the accepted results and effectiveness related to that particular product
But sometimes, this can also result due to failed regulatory regulations.
If there is a product to recall, the pharma drug manufacturer is bound to inform the relevant drug regulatory authority. The main aim is to investigate the recalled product and to study the underlying cause. The drug manufacturer also provides relevant information about production processes such as facilities, equipment, and all other related data.
In response to data provided by the drug manufacturer and investigation performed by itself, the regulatory body reviews its drug review and approval procedure. If it finds that its drug review and approval procedures are the leading cause of product recall, it changes its regulations. The main aim is to correct any loopholes in the system and remove any deficiencies. These loopholes and efficiencies can hinder providing safe and effective drugs for the patient, doctors, and other intended users
Feedback from pharma product manufacturer
Pharma manufacturers often provide feedback to their concerned regulatory bodies about different aspects of drug manufacturing. This feedback comes in response to factors such as regulatory body inspection, failure in compliance, and difficulty in conducting various operations. In addition to these, a pharma manufacturer can also give feedback without any inspection or a warning, and it can be regular a feedback.
The feedback can be related to the different departments, such as raw materials, packaging, storage, and equipment.
The regulatory body reviews this feedback and gauges its drug review, and approval regulations. If the regulatory body assumes that existing rules and regulations are enough to answer the question, the pharma regulatory body keeps the existing rules and regulations unchanged. On the other hand, if pharma regulatory body assumes that existing rules and regulations need change and are insufficient to answer pharma manufacturer questions, it tries to update its regulation.
Some updates regarding drug review and approval
Let’s discuss some updates regarding drug review with respect to China United States and EMA
National medical products administration - China
Announcement on issuing 5 documents router registration inspection
Center for Food and Drug Inspection announced that any drug manufacturer that desires to register a new product must file documents to facilitate pharma product manufacturers filing registration for a new drug. NBA organizes the inspection. Its main purpose is to standardize the work process of drug registration, inspection, quality, and efficiency of registration inspection. The document is as follows
Work Procedures for Drug Registration Inspection(Trial)
Key Points and Determination Principles of Drug Registration Inspection(Pharmacological and Toxicological Study)
Key Points and Determination Principles for Drug Registration Inspection(Drug Clinical Trials)
Key Points and Determination Principles of Drug Registration Inspection(Pharmaceutical Development and Manufacturing Site)
Work Procedure for Collaborative Drug Registration Inspection of Manufacturing Site and Pre-market Good Manufacturing Practice (GMP) Inspection
Regulations for the administration of drug clinical trials institution
National medical products administration NMPA has devised a regulation for clinical drug administration in a joint venture with the National Health Commission. The central part is the requirement of NMPA to record filing. Previously it was an accreditation, which is now changed.
This guidance was released on November 29, 2019, effective from December 1, 2019.
European Medicines Agency
New regulations of EMA
The European Medicine Agency has decided to add structures and processes adopted during COVID-19 as a part of the regular registration process. Previously it was only during the COVID-19 pandemic. However, considering its effectiveness and efficiency, the European regulatory authority has made it part of a regular drug registration process. For every new drug registration process, it must be followed.
These new regulations were proposed on February 1st, 2022, and became effective on 1st March 2022
Some highlights of the new regulatory requirements include medicine shortages and reporting critical medicine shortages.
European shortages monitoring platform
The European Medicine Agency plans to list short medicines and drugs by implementing a shortages monitoring platform by 2025. The basic function is to facilitate data collection and reporting by companies and member states on the products that are subject to shortages and have disturbed the supply-demand ratio.
The EMA is also tasked with coordinating 12 European Union expert members in producing evidence for member states on high-risk medical devices.
The shortages monitoring platform is also tasked with effectively responding to critical or non-critical emergencies by following activities.
Reinforcing the COVID - 19 objective task force to provide scientific advice and evidence related to medicines that can possibly face shortage. It also plans to monitor the existing drugs, and see, if they can become short
Using relevant data in conducting vaccine effectiveness tests
Managing crisis preparedness and response by investing in real world evidence. It should establish a pan – European network, having real world data, capable of providing real world evidence to EMA scientific committees
United States FDA
Accelerated approval is a fast-track drug approval program. This is used for drugs that are critical such as in the case of life-threatening disease or pandemic. This approval approves NDA before the pharma drug manufacturer provides effectiveness measures.
The accelerated approval uses less traditional methods called surrogate endpoints for evaluating drug effectiveness. Instead of studying the impact and effects on patient functions and studying survival rates, surrogate endpoints use laboratory data or findings that can relate to a drug benefit. These tests are conducted in a lab environment that can create natural and human-like conditions.
Orphan drug program
An orphan drug program is the development of a drug meant to cure rare diseases. The United States FDA can grant orphan drug designation to a drug that it feels satisfied which is used to cure a rare disease.
Under the orphan drug program, FDA provides sponsors with the following benefits.
tax credit for clinical trials
exemption to pay user fees
excluding for seven years after approval
About the Author
Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.