1. What is the Chemxpert database?

Chemxpert database is a techno-commercial information platform developed and operated by Lifescience Intellipedia Pvt. Ltd. Our data provides valuable insights regarding sourcing, marketing, development, and regulatory functions for the entire Lifescience industry. The different industries covered by our data encompass APIs, FDFs, pharma intermediates, paints, dyes, polymers, biotechnology, biochemical, food additives, nutraceuticals, etc.

2. How can I subscribe to the Chemxpert database?

You can gain access to the Chemxpert database after subscribing to it by visiting this link: - https://chemxpert.com/pricing

3. How many countries' data is available on your portal?

The Chemxpert database covers more than 200 countries. We are working in the direction of expanding our data coverage in more countries.

4. What are the different sources you use for obtaining information?

The different sources we use for data collection are as follows: - • Primary researc • DMF, ANDA, & CEP list • Conferences, Exhibitions, & Tradeshow • Company annual reports • DMF, ANDA, & CEP list • Subject matter experts & KOL survey. Apart from these, our other valuable sources include application-wise manufacturers list, subscribed and non-subscribed databases, corporate partners, US FDA Orange book, publicly available sources, industry associates, national statistics, regulatory websites, etc. You can gain access to the Chemxpert database after subscribing to it by visiting this link: -https://chemxpert.com/sources

5. What is the expected time for account activation?

Your Chemxpert account will be activated instantly if the payment is made through our website. If you choose to use RTGS, NEFT, or IMPS systems for payment, your account will be activated within 24 hours.

Navigating Regulatory Compliance in Pharmaceutical Industry

Admin
10 May 2024

Introduction:

In order to ensure the safety, efficacy and quality of medicines, the drug industry operates in a rigorous regulatory framework. The key role in the supervision of pharmaceutical products is played by key regulatory bodies such as the FDA in the US, DMF submissions to support the approval of medicinal products, and the CDSCO in India. In this blog, explore the tasks of these regulator bodies and examine how databases such as Chemxpert, which provide crucial information on legislation, have revolutionized efforts to comply with it.

Understanding Regulatory Authorities:

1. FDA (Food and Drug Administration):

In order to protect public health through the supervision of food, drugs, biologics, medical devices and cosmetic products, FDA is the United States' most important regulatory agency.
Approval for medicinal products, conduction of clinical trials and standards for the manufacturing and quality control of medicinal products are established by the FDA.
It shall carry out the assessment of new applications for medicinal products, conduct inspections at manufacturing facilities and monitor safety and effectiveness of marketed medicines by means of post market surveillance.
To be able to sell medicinal products in the United States, companies must obtain FDA approval and comply with strict regulatory requirements.

2. CDSCO (Central Drugs Standard Control Organisation):

The CDSCO is India's National Authority for the Regulation of Pharmaceuticals, Cosmetics and Medical Devices.
It is managed by the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
The CDSCO shall approve medicinal products, supervise clinical trials and ensure that safety and quality standards are respected.
In India, CDSCO has Zone Offices, Subzones and central laboratories.

3. EMA (European Medicines Agency):

The European Medicines Agency assesses and monitors the safety and efficacy of medicinal products operating within the European Union.
Following a rigorous scientific assessment, it grants marketing authorizations for medicinal products throughout the EU.
In order to market their products in the EU, pharmaceutical companies must be approved by the EMA.

4. ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use):

The ICH is an international initiative involving regulatory bodies and representatives of the pharmaceutical industry from around the world.
In order to promote the harmonization of regulatory requirements and to ensure the quality, safety and efficacy of pharmaceutical products worldwide, it develops guidelines and standards.

5. MHRA (Medicines and Healthcare products Regulatory Agency):

The MHRA is responsible for ensuring the safety, quality and efficacy of medicinal products and medical devices in the United Kingdom.
It assess the safety of medicinal products before they are placed on the market, monitor their safety as soon as they become available to the public and take measures to protect health if there is any concern about safety.
Pharmaceutical companies must receive MHRA approval and comply with UK regulations if they wish to market their products within the United Kingdom.

6. TGA (Therapeutic Goods Administration):

The responsibility for the safety, quality and effectiveness of medicinal products such as medicines, medical devices, or blood products lies with the Therapeutic Goods Administration which operates in Australia.
It assesses and monitors the safety and performance of these products throughout their lifecycle, from pre-market evaluation to post-market surveillance.
For pharmaceutical companies to market their products in Australia, approval from the TGA is necessary for compliance with national regulations.

Role of Chemxpert Database:

The Chemxpert database aggregates and organizes regulatory information from around the world.
It provides users with access to current regulatory requirements, guidelines and standards so as to facilitate compliance efforts and decision making.
Chemxpert offers a range of features such as search capabilities, alerts for updates to legislation and custom dashboards that will meet the specific needs of healthcare sector.
Chemxpert enables regulatory professionals to stay informed, reduce the risk of compliance and speed up authorizations through centralizing regulatory information and simplifying access to related data.
In order to navigate the complicated regulatory environment, improve efficiency and ensure compliance with legislation on all markets, this database is an invaluable tool.

Conclusion:

In order to comply with regulatory standards, it is essential to ensure the safety of patients and the quality of products in a highly regulated pharmaceutical sector. Pharmaceutical companies developing and marketing medicines around the world are very interested in understanding the role of regulators such as FDA, DMF or CDSCO. In order to facilitate regulatory compliance efforts, provide timely access to critical regulatory information and enable companies to take a confident approach to the regulatory environment, innovative solutions such as Chemxpert database are used.