When do i need fda approval

Ages and Stages. Healthy Living. Safety and Prevention. Family Life. Health Issues. Tips and Tools. Our Mission. Find a Pediatrician. Text Size. Page Content. This article provides information about the FDA's drug approval process. Animal Testing: Before testing the drug on people, the company must test the new drug on animals to find out whether it has the potential to cause serious harm i. These results must include the drug's composition and manufacturing and the proposed plan for testing the drug on people.

There are 4 phases of clinical trials, starting with small-scale trials, followed by large-scale trials.

After the clinical trials, the researchers then submit study reports to the FDA. The FDA reviews the application and makes a decision to approve or not approve the drug. The information contained on this Web site should not be used as a substitute for the medical care and advice of your pediatrician. Business name registration reflecting new ownership. Name of new qualified person. Updated contact details A qualified person has the responsibility to comply with the technical requirements of the FDA or discuss or clarify matters with the FDA when submitting technical requirements or engage the FDA officials when conducting inspection or post-market surveillance activities.

The qualified person may also be the duly Authorized Person of the establishment. Importer, Exporter, Wholesaler 8, BizPortal is now available.

An application for renewal of license filed after days shall be considered expired and the application shall be subject to a fee equivalent to the total surcharge or penalty plus the initial filing fee and the application shall undergo the initial filing. The FDAC personnel will respond to the email and provide to the applicant company the designated document tracking number of the application.

For pre-assessment, no specific timeline is committed in the Citizen's Charter. New case should be created selecting the previous application's type eg. Initial, Renewal, Reapplication or Amendment instead of reapplying the denied pre-assessment.

Denied Initial application on E-portal V2 should be applied on the same case number instead creating a new case unless declared on the issued Letter of Denial. Amendment should be filed first if there are changes.

Renewal should be applied first before applying for an amendment. Amendment should be filed on the same case number used in the renewal application.

A system-generated email notification of complete requirements will be sent to the registered E-mail. On the other hand, you may also download the result of pre-assessment under the Generated Documents tab in the case number.

Right click on the case number. Select "Summary" and look for the Generated Documents tab. Once the document appears, tick the file then click download.

Food establishments with License to Operate as Manufacturer and Trader who directly import and use raw materials, ingredients and food additives for their own use or for further processing to manufacture a processed food product, need not secure a CPR for the raw materials, ingredients and food additives. For further guidance on registration requirements and food regulations, please refer to Administrative Order No.

You need to fill up Initial Application Form and upload a scanned copy of the following documents in the system during application:. All food establishments applying for product registration should have a valid License to Operate issued by FDA.

For locally produced products, the product being applied should be included in the LTO of the manufacturer. The Case Number will close upon assessment of initial, amendment, renewal or reapplication data capture applications having incomplete submission of documentary requirements. You will then need to upload again ALL previous and current documents and file a new application using a new case number. If your successful pre-assessed application is DENIED , an email notification with attached Letter of Denial will be sent to the registered email of E-portal account holder.

Pay the corresponding reapplication fee. Otherwise, you will receive an email notification with attached Results of Pre-assessment. Fees and charges will be computed by the system based on the number of years 2, 3, 4 or 5 years validity applied for and type of product. You may refer to Administrative Order No.

Payments through Bancnet Online and LandbankOncoll are also accepted. Only Initial applications for Food Supplement are required to submit a representative sample in commercial presentation consistent with the E-Registration application. It should be properly labelled with the respective case number, packaged accordingly to protect the contents and submitted to the Food and Drug Administration Main Office Building within ten 10 days upon payment of assessed fee through either of the following means:.

A previously registered product initially for local distribution shall be allowed to be exported using the same CPR as long as the following conditions are met, and labelling and standards of the importing country are likewise met:. Amendment application of Packaging Design for export product shall be made and labels in the language of the importing country shall likewise be submitted. Applications filed through the E-Registration system are processed within 20 working days.

You may track the applications through the Process Map function of the system in the electronic portal. The name and address of the importer is reflected on the CPR which is needed during importation and release of goods from the Bureau of Customs. An authorized representative handling multiple companies must secure a separate user account and password for each respective company.

You must secure a notarized authorization letter from the company with a valid License to Operate Number being represented or the company account holder. Send the request for a User Account to [email protected] following the format specified below with the scanned notarized authorization letter:. Be sure to check the Spam folder of your e-mail if you have not received a reply within 3 working days.

You may also use your E-LTO User Account and Password for E-Registration by having it validated through a request sent via email to [email protected] following this format:. You will need to renew these by sending a request via email to [email protected] following this format:. This procedure is for Data Capture only wherein it is intended for applications with existing CPR and denied applications in the old version 1 of E-Registration.

In reapplication, declare the old application number only under General information step. Once the case number is already in your inbox account, you can click the case number and view the Amendment Summary Table which reflects the result of your application. If the application is disapproved, you can see the remarks or reason for its disapproval on the right side of the table. Same as the requirements for conventional food products as stipulated in the Administrative Order with the addition of stability study, Certificate of Analysis COA of the finished product and as applicable, safety data e.

LD Toxicity Test. For food supplements containing herbs which are not listed in any official pharmacopeia and substances with no established safe levels. We accept results for actual and accelerated shelf life study. If the shelf life study is on-going, results for at least 6 months is allowed. If not company owned, either the manufacturer or distributor should register the product.

You may also refer to Food Chemical Codex for specifications of raw materials on limits for heavy metals. As per Republic Act otherwise known as the Food Safety Act of , Codex standards shall be adopted except when these are in conflict with what is necessary to protect consumers and scientific justification exists for action taken. Sending additional files to [email protected] is not acceptable. The pre-assessor will assess the application based on the completeness to the requirements specified on FDA Circular No.

The result of pre-assessment will be automatically sent to the registered email of the account holder. The evaluator will assess your application based on the uploaded requirements in compliance with FDA Circular No. Any additional documents that are submitted after filing of applications shall not be considered.

You may call us at loc. Yes, a clear, readable, complete artwork or proposed label may be submitted when you apply for product registration.

No, labels of products exclusive for export market only shall comply with the existing labeling regulations of the importing country or country of destination of the products. Labels of products for local distribution should conform to the local labeling regulations as stipulated in Administrative Order , while the labels for export market should follow the existing labeling regulations of the importing country.

A separate label for export market must be printed in order to comply with the labeling regulations of the country of destination of your products. No, labels of imported products shall declare the corresponding English translation of mandatory label information. A provisionary sticker can be used for a maximum of six months only. Labels of products in the market should be compliant with the labeling regulations.

Pictures of the product in commercial presentation, from at least 2 different perspectives must also be submitted. You need to upload a letter of intent stating the changes made on the label and the revised label.

An amendment fee of PhP No, you cannot use the brand name of products previously registered with FDA under a different company unless you have authorization from the brand name owner. If the product has multiple SKUs with different designs but with the same formulation, manufacturer, brand name and product name including description, you only need to upload all labels of different packaging sizes on your application.

Stickering is allowed, provided that the sticker is durable and not easily removed. The label information should be printed on, or on a remedial sticker on the label itself and it is only allowed for six months from the date of approval. However, the importing company must have a valid License to Operate as Food Importer, and supporting documents must be submitted during application as proof that the product is exclusively imported or manufactured for that particular Importer.

All labels must carry a corresponding English translation of the mandatory labeling information written in foreign language, as stipulated in Administrative Order All prepackaged, processed food products must follow the labeling regulations. After the clearance is issued to the requesting party, they should contact the FDA-Regional Field Office at [email protected] for the schedule of inspection.

Reference: FDA Circular You may email [email protected] for this type of requests. Submit this type of request to [email protected]. The requesting party should have a valid License to Operate and Certificate of Product Registration to be able to join the exhibit abroad and Payment of Php All processed food and food products complete list is in AO including:.

However, only food products duly registered with FDA are allowed to conduct sales promotional activities. Social, civic, political, religious, educational, professional and other similar organizations which extend promotional activity among their members.

Provided that the promotional activity is not considered sales promotion campaign as defined under these Rules. Reference: DAO No. Client must email [email protected]. The subject of the email shall follow the following format:. Submit requirements to [email protected]. The application will undergo pre-assessment based on the completeness and correctness of the requirements.

Otherwise, the submitted application will not be pre-assessed. If the requirements are complete and compliant, an email will be sent to the company with instruction to proceed with the payment.

If the application is incomplete, the applicant will be advised to secure a new appointment schedule to submit the application for pre-assessment. The client must request for a new DTN and schedule of appointment. Submit the requirements, proof of payment and CFRR pre-assessment form to [email protected] through file-sharing platforms. Please wait for the posting and verification of your payment before you submit the documents.

For amendment including extension, the fee is Php At least thirty 30 days before the actual commencement of the sales promotion per Article of R. Products like food and dietary supplements can be marketed without obtaining prior approval from the FDA. However, you have to comply with the general regulatory requirements listed below. Medical device registration and listing is one of the mandatory requirements for all types of medical devices.

Registration is not mandatory for cosmetic products. Cosmetic firms can voluntarily register their establishment and submit the formulations. Companies marketing cosmetic products should comply with the below-listed requirements.