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PPB Dossier Gap Check

Describe your product, mark what you have, and get a CTD Module 1-5 gap report that tells you whether you are ready to file with the PPB. This is a paid tool: your first 3 exports are free, then each export or printed report uses one credit.

1. Describe your product

We tailor the CTD requirements to your product, so the checklist and gap report only show what actually applies. Nothing is uploaded; this stays in your browser.

Product type

BCS class

Where is it manufactured?

Contract manufactured?

2. Dossier readiness

0 of 0 applicable items in hand - 0 blocking gaps

Set your profile

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0% ready

Disclaimer

This tool summarises common requirements for PPB CTD dossier submissions and tailors them to a simplified product profile. It is a planning aid, not regulatory advice. Always refer to the current PPB "Guidelines on Submission of Documentation for Registration of Pharmaceutical Products" and the specific requirements for your product's classification. Requirements vary for biologicals, biosimilars, and ATMPs.

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Our regulatory team compiles and reviews CTD dossiers for PPB submission, including gap analysis against current PPB and EAC requirements.

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What is a PPB Product Registration Dossier?

A PPB product registration dossier is the complete technical and administrative file submitted to Kenya's Pharmacy and Poisons Board (PPB) to obtain marketing authorisation for a medicine. It is organised in the internationally recognised Common Technical Document (CTD) format, the same five-module structure used across the East African Community and by stringent regulators worldwide. Each module groups a specific class of evidence, from administrative paperwork and product labelling through to chemistry, manufacturing, and clinical study reports.

For a Kenyan submission the dossier must show that the product is safe, effective, and of consistent quality under local conditions. Because Kenya sits in WHO Climatic Zone IVb (hot and humid), the PPB expects stability data generated at the harsher 30 degrees C and 75 percent relative humidity long-term condition rather than temperate-zone data. Generic applicants also need to demonstrate therapeutic equivalence, usually through a bioequivalence study, while every applicant supplies a Certificate of Pharmaceutical Product (CPP) and evidence of Good Manufacturing Practice.

Assembling a CTD dossier is detail-heavy, and a single missing CPP, expired GMP certificate, or incomplete stability set is one of the most common reasons a submission is queried or rejected. This checklist breaks the dossier into its five CTD modules so you can track document completeness before you file, reduce avoidable screening queries, and keep your registration timeline on track.

How to Use This Dossier Checklist

Work through each CTD module

The checklist is grouped into Modules 1 to 5, following the CTD structure the PPB uses. Start at Module 1 (administrative and product information) and move through quality, nonclinical, and clinical evidence, ticking each item your dossier already contains.

Track your completion progress

As you check items, the progress bar and per-module counters update automatically, and your selections save in your browser. You can close the tab and return later on the same device without losing your place.

Confirm against current PPB guidance

Use the checklist to spot gaps, then verify each requirement against the latest PPB guidance for your product class, since requirements differ for generics, biologicals, biosimilars, and new chemical entities.

Print or save your dossier status

Once you have reviewed every module, use the Print / Save PDF button to produce a snapshot of outstanding items to share with your team or your Local Technical Representative.

Frequently Asked Questions

About PPB product registration dossiers and the CTD format

What is a PPB product registration dossier?+

A PPB product registration dossier is the full set of administrative, quality, nonclinical, and clinical documents submitted to Kenya's Pharmacy and Poisons Board to obtain marketing authorisation for a medicine. It is compiled in the Common Technical Document (CTD) format, which organises the evidence into five standard modules. The dossier proves that the product is safe, effective, and consistently manufactured to an acceptable quality standard.

What are the five CTD modules?+

The Common Technical Document has five modules. Module 1 holds regional administrative and product information such as the application form, labels, and Certificate of Pharmaceutical Product. Module 2 contains the CTD summaries and overviews, Module 3 covers quality (chemistry, manufacturing, and controls), Module 4 holds the nonclinical study reports, and Module 5 holds the clinical study reports. This checklist follows the same five-module structure.

Do I need a Certificate of Pharmaceutical Product (CPP) to register in Kenya?+

Yes. The PPB requires a Certificate of Pharmaceutical Product issued in the WHO format by the medicines regulator in the country of origin or export. The CPP confirms that the product is authorised and that the manufacturing site complies with Good Manufacturing Practice. It is a Module 1 document and a frequent source of queries when it is missing, expired, or does not match the product details in the rest of the dossier.

What stability data does the PPB expect for Kenya?+

Kenya falls within WHO Climatic Zone IVb, so the PPB generally expects long-term stability data generated at 30 degrees C and 75 percent relative humidity, supported by accelerated data at 40 degrees C and 75 percent relative humidity. As a guide, applicants usually provide at least six months of accelerated data and twelve months of long-term data, though the exact requirement depends on the product. Always confirm the current expectation for your specific product class.

Can a foreign manufacturer register a product directly with the PPB?+

A manufacturer based outside Kenya normally appoints a Local Technical Representative (LTR) to hold the registration and act as the local regulatory contact. The LTR submits the dossier, liaises with the PPB, and takes responsibility for in-country obligations such as pharmacovigilance. The technical content of the dossier is the same; the LTR simply provides the local legal presence the PPB requires.

Is this dossier checklist free? Do I need to sign up?+

Yes, the checklist is completely free and needs no account or sign-up. Your progress saves automatically in your own browser using local storage, so nothing is uploaded to a server. You can return to the same device later and continue where you left off, or use the reset button to start over.

Does this checklist replace the official PPB guidelines?+

No. This tool is a planning aid that summarises commonly required dossier documents; it does not replace the official PPB guidance. Requirements vary for generics, biologicals, biosimilars, and new chemical entities, and the PPB updates its guidelines over time. Always confirm each requirement against the current PPB 'Guidelines on Submission of Documentation for Registration of Pharmaceutical Products' before you file.

How long does PPB product registration take?+

Review timelines depend on the product type, the completeness of the dossier, and the PPB's current workload, so they vary from one application to another. A complete, well-organised CTD dossier with no missing documents moves through screening faster, because incomplete submissions are queried and sent back for correction. Using a checklist to confirm completeness before filing is one of the simplest ways to avoid avoidable delays.