Ministry of National Health Services Regulations & Coordination Islamabad
Drug Regulatory Authority of Pakistan
Ministry of National Health Services Regulations & Coordination Islamabad
Drug Regulatory Authority of Pakistan
Pharmaceutical Evaluations and Registration Division is responsible for the evaluation, assessment and registration of pharmaceuticals drugs for human beings, animals and to perform other functions connected therewith and assigned by the Board.
| Type | Subject | Division | Attachment |
|---|---|---|---|
| Application Form | Application Form for Registration of a Drug for Local Manufacture | Registration | Download |
| Application Form | Application Form for Registration of an Imported Drug | Registration | Download |
| Application Form | Application Form for Renewal of Registration of all Kinds of Drugs | Registration | Download |
| Application Form | Statement of Quarterly Production | Registration | Download |
| Notification | NOTIFICATION-SRO 307(I)/2017 Amendments in the Drugs | Registration | Download |
| Notification | Import of Active Pharmaceutical Ingredients (APIs) / Drug Substances | Registration | Download |
| Notification | Submission of Differential Fee and Deficiencies for Submitted Registration Dossiers | Registration | Download |
| Notification | Circular for Submission of Renewal Application With Respect to Post Registration Variation | Registration | Download |
| Notification | Import of Active Pharmaceutical Ingredients (APIs) / Drug Substances (Dt.Up.04-04-2017) | Registration | Download |
| Notification | Packaging Materials for Pharmaceutical Preparations | Registration | Download |
| Notification | Packaging Materials for Pharmaceutical Preparations | Registration | Download |
| Notification | Provisional Draft List of Registered Drugs | Registration | Download |
| Notification | Submission of Differential Fee and Deficiencies for Submitted Registration Dossiers | Registration | Download |
| Notification | Compliation of Data Relating To Registration of Drugs | Registration | Download |
| Advisory | Review of Formulations Of Ciprofloxacin Oral Suspension | Registration | Download |
| Check List | Documents Required for Approval of Post-Registration Variations | Registration | Download |
| Check List | Check List for Scrutinization of Registration Application / Dossiers | Registration | Download |
| Check List | Documents Required for Approval of Post-Registration Variations | Registration | Download |
| Check List | Check List for Scrutinization of Registration Application / Dossiers | Registration | Download |
| Check List | CTD Pre-Submission Screening Checklist (Form 5-F) for registration of human drugs | Registration | Download |
| Circular | Circular for Submission of Renewal Application With Respect to Post Registration Variation | Registration | Download |
| Circular | Packaging Materials for Pharmaceutical Preparations | Registration | Download |
| Circular | Export Facilitation For Pharmaceutical Manufacturers | Registration | Download |
| Circular | Export Facilitation For Pharmaceutical Manufacturers | Registration | Download |
| Circular | Use of Methylene Chloride, Sodium Cyclamate and Other Organic Solvents in Formulations of Pharmaceutical Products | Registration | Download |
| Circular | Submission Of Renewal Application Of Biological Drugs In Biological Division | Registration | Download |
| Guidelines | Guidelines for authorized officers under special SROs for issuance of NOC | Registration | Download |
| Guidelines | Guidelines undertaken for performance of Pharmacovigilance activities | Registration | Download |
| Guidelines | Draft Guideline for Priority Review and Accelerated Approval of Registration / Market Authorization (1st Edition) [“stakeholders may submit their comments to Division of Pharmaceutical Evaluation & Registration within fifteen days ( till date: 15-Nov-2019 ) on the following email address: addl-dir.pe.reg@dra.gov.pk ]” | Registration | Download |
| Guidelines | Draft Guideline for Preparation of Summary of Product Characteristics (SmPC) (CTD Module 1.5.14) (1st Edition) [“stakeholders may submit their comments to Division of Pharmaceutical Evaluation & Registration within fifteen days on the following email address: addl-dir.pe.reg@dra.gov.pk Dated: 04th Nov,2019]” Registration | Registration | Download |
| Guidelines | Draft Guidelines on Post Registration Variations to Registered Pharmaceutical and Biological Drug Products (1st Edition) ,[“stakeholders may submit their comments to Division of Pharmaceutical Evaluation & Registration within fifteen days on the following email address: addl-dir.pe.reg@dra.gov.pk Dated: 04th Nov-2019]” | Registration | Download |
| List of Drugs | Provisional List of Pending registration applications with PEC of PE&R Division | Registration | Download |
| List of Drugs | Provisional List Of Renewal Applications Received Within Due Date | Registration | Download |
| List of Drugs | List of renewal application of year 2018 deferred by Registration Board for the rectification of shortcomings | Registration | Download |
| List of Drugs | List of renewal application of year 2018 approved by Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 238th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 239th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 240th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 241th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 242th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 243th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 244th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 245th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 246th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 247th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 248th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 249th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 250th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 251th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 252th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 253th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 254th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 255th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 256th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 257th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 258th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 259th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 260th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 261th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 262th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 263th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 264th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 265th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 266th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 267th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 268th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 269th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 270th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 271th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 272th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 273th meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes for 274th Meeting of Registration Board held on 28-29th August, 2017. | Registration | Download |
| Minutes of Meeting | Minutes for 275th Meeting of Registration Board held on 25-27th October, 2017. | Registration | Download |
| Minutes of Meeting | Minutes for 276th Meeting of Registration Board held on 22-25th November, 2017. | Registration | Download |
| Minutes of Meeting | Minutes of 277th Meeting of Registration Board held on 27-29th December, 2017 | Registration | Download |
| Minutes of Meeting | Minutes of 278th Meeting of Registration Board held on 29-31st January, 2018 | Registration | Download |
| Minutes of Meeting | Minutes of 279th Meeting of Registration Board held on 28th February to 2nd March, 2018 | Registration | Download |
| Minutes of Meeting | Minutes of 280th Meeting of Registration Board held on 15th March, 2018 | Registration | Download |
| Minutes of Meeting | Minutes of 281st Meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 281st Meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 282st Meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 283st Meeting of Registration Boar | Registration | Download |
| Minutes of Meeting | Minutes For 284th Meeting Of Registration Board Held On 31st July & 1st August, 2018 | Registration | Download |
| Minutes of Meeting | Minutes Of 285 Meeting Of Registration Board Held On 3rd To 4th October, 2018 | Registration | Download |
| Minutes of Meeting | Minutes Of 286 Meeting Of Registration Board Held On 14th To 16th November, 2018 | Registration | Download |
| Minutes of Meeting | Minutes Of 287 Meeting Of Registration Board Held On 3rd & 4th January, 2019 | Registration | Download |
| Minutes of Meeting | Minutes Of 288 Meeting Of Registration Board Held On 14th-15th February, 2019 | Registration | Download |
| Minutes of Meeting | Minutes Of 289 Meeting Of Registration Board Held On 14th-16th May, 2019 | Registration | Download |
| Minutes of Meeting | Minutes Of 290 Meeting Of Registration Board Held On 3rd-4th July, 2019 | Registration | Download |
| Minutes of Meeting | Minutes Of 291 Meeting Of Registration Board Held On 2nd-4th Sep, 2019 | Registration | Download |
| Minutes of Meeting | Minutes of 292 Meeting of Registration Board | Registration | Download |
| Minutes of Meeting | Minutes of 293 Meeting of Registration Board | Registration | Download |
| Policy | Policy for Inspection of Manufacturer Abroad (For Imported Drugs) | Registration | Download |
| Policy | Policy Guidelines Regarding Reference Regulatory Authorities for Registration of Drugs | Registration | Download |
| SOPs | PROCEDURE FOR REGISTRATION OF DRUGS | Registration | Download |
| SOPs | SOPs for GMP Certificate | Registration | Download |
| SROs | Provisional Draft List of Registered Drugs | Registration | Download |
| SROs | Common Technical Document (CTD) for Registration of Human Drugs | Registration | Download |
