The presentation discusses the Certificate of Pharmaceutical Products (COPP), which certifies the status of pharmaceutical products and their applicants as per WHO standards. It outlines the required information on the COPP, including certificate numbers, exporting and importing countries, and the types of drugs it covers. Additionally, it emphasizes the responsibilities of regulatory affairs professionals and the importance of complying with varying national regulatory requirements for drug approval.

1. PRESENTATION ON
CERTIFICATE OF
PHARMACEUTICAL PRODUCTS
Mansoor Ansari
Student Of B.pharm 4th
Year (7 sem)
Shakti College Of Pharmacy Balrampur UP

2. POINTSTO BE COVERED IN THIS TOPIC
1.Certificate of a pharmaceutical product
2. This certificate, which is in the format recommended by WHO, establishes the status of the pharmaceutical product and
of the applicant for the certificate in the exporting country.
The COPP provides the information of the following:
3.1. Certificate number of COPP
4. The certificate number of COPP should be enclosed in the specified format
recommended by WHO.
5.2. Name of exporting country (certifying country)
6. The name of the country (certified country) to which the product is being exported
must be mentioned in the certificate.
7.3. Name of importing country (requesting country)
8. The name of the countries (requesting countries) from which the product is being
imported from certified country must be mentioned in the certificate.

3. º Types of drugs for which COPPs may be issued
Approved drug products
Active pharmaceutical ingredients (API)
Over the counter drug (0TC) products
Unapproved drug products
Homeopathic drugs

4. RESPONSIBILITY OF REGULATORYAFFAIRS PROFESSIONALS
 Ensuring that their companies comply with all of the regulations and
 laws pertaining to their business.
 Working with federal, state and local regulatory agencies and
 personnel on specific issues related to their business.
 Advising companies on the regulatory aspects and climate that would
 affect their proposed activities.
 Keep in touch with international legislation, guidelines and customer practices.
 Keep up to the date with a company’s product range.
 Collect, and evaluate the scientific data that their research and development colleagues are generating.
 Formulate regulatory strategies for all appropriate regulatory submissions such as domestic, international and/or
contract projects.
 Participate in R&D training, Pilot plant Scale Up, and Post Marketing
 Surveillance (ADR).
 Manage and review audit reports and compliance, regulatory and
 customer inspections.
 Provide accurate and complete information about the quality, safety
 and effectiveness of the product to the physicians and other healthcare professionals.

5. REGULATORY REQUIREMENTS FOR DRUG APPROVAL
 Currently different nation’s have to follow different requirements for
 the regulatory approach of drug
 Regulatory approach for the NAA, there fore, it is necessary to have knowledge about regulatory requirements for
NAA of each country.
 New Drug Application [NDA] is an application submitted to the
 respective regulatory authority for permission to market a new drug.
 To obtain this permission a sponser submits preclinical and clinical test
 data for analyzing the drug information and description of
 manufacturing Procedures.
 This process of evaluation is made to ensure that the sufficient date and
 the required information – have been submitted in each justifying and filling application form.