The guidelines are available in the "National Biosafety Guidelines 2005 (amended 2024)", "Pakistan Biosafety Rules 2005 (amended 2024)", and “SOPs for import of GMOs for FFP”, which can be accessed through the Pak BCH License Portal.

To apply for a field trial, a detailed application including the trial design, risk assessment, and containment measures, as per the formats provided in the "National Biosafety Guidelines 2005 (amended 2024)".

The commercialization application requires a comprehensive dossier including safety assessments, economic impact analysis, and proposed management plans, as detailed in the National Biosafety Guidelines 2005 (amended 2024).

No, hard copies of the applications are not required to submit. Application must be submitted online through the provided IBCs which are issued with login credentials for Pak-BCH Portal Login.

The application formats are included in the "National Biosafety Guidelines 2005 (amended 2024)", which are available on the Pak BCH License Portal.

The fee related to the application varies according to the category. It is given as:

For more information, visit: The National Biosafety Guidelines 2005, (amended 2024)

For assistance, contact the support team via the contact information provided on the Pak BCH License Portal or refer to the National Biosafety Guidelines 2005 (amended 2024) for detailed instructions.

GM crop field trials are conducted firstly under confined environment to evaluate the performance, environmental safety, and agronomic benefits of genetically modified (GM) crops. These trials assess factors like pest resistance, herbicide tolerance, yield, and environmental impacts prior to open field trial.

All research institutions, universities, and research organizations involved in biotechnology research are required to apply for GM crop field trials through notified IBC. 

The application format for field trial permission is given in Chapter 11 of the National Biosafety Guidelines, 2005 (amended 2024).

Pak-EPA issues licenses for field trials after approval from NBC. The validity of the license is for 2 years.

Cotton varieties containing single-gene known events are exempted from field trials permission from NBC. However, the proponent shall inform Pak-EPA before submitting varieties for National Cotton Varietal Trials (NCVT).

Applicants must submit a comprehensive application, including detailed biosafety risk assessment reports and an application according to the format in Chapter 14 of the National Biosafety Guidelines 2005 (amended 2024). Moreover, international safety approvals, intended usage information, and a complete import plan. Additionally, it must contain certificates of origin and safety testing data in accordance with Pakistan Biosafety Rules 2005 (amended 2024).

The maximum processing time for a biosafety license is 120 days after the completeness of the submitted application. Generally, the review process by the Technical Advisory Committee (TAC) and the National Biosafety Committee (NBC) may take several weeks to months. Applicants are advised to plan accordingly and submit applications well in advance.

Pak-EPA reviews comprehensive biosafety risk assessment reports and evaluates compliance with The National Biosafety Guidelines 2005 (amended 2024). Additionally, random sampling of imported consignments is conducted upon arrival to verify compliance and assess for any potential risks.

No, GM soybeans imported under a biosafety license for FFP purposes are strictly prohibited from being used for research, field trials, or cultivation. Separate approvals and licenses are required for any other use, in accordance with The National Biosafety Guidelines 2005 (amended 2024) and the Cartagena Protocol. Any unauthorized use will be considered a violation of the license terms and subject to regulatory action.

No, all biosafety licenses issued for GM soybeans are non-transferable. Each importer must apply separately for a license in accordance with The National Biosafety Guidelines 2005 (amended 2024) and Pakistan Biosafety Rules 2005 (amended 2024).

All public/private sector institutes/organizations engaged in GMOs-related research activities are required to constitute an Institutional Biosafety Committee in compliance with Rule 8 of the Pakistan Biosafety Rules, 2005 (amended 2024).

The composition of the IBC is in compliance with the Rule 8 of the Pakistan Biosafety Rules, 2005 (amended 2024) and also mentioned in Chapter 5 of National Biosafety Guidelines, 2005 (amended 2024).

IBC will ensure that research is conducted safely and complies with Rule 9 of the Pakistan Biosafety Rules, 2005 (amended 2024). All applications related to genetic manipulation work, field trials, commercialization, and import of GMOs for Food, Feed, or Processing (FFP) will be reviewed by IBC prior submission to NBC for approval.

In the case of any change in IBC composition, IBC shall be re-notified.

The list of notified IBCs can be retrieved from the online portal of Pakistan Biosafety Clearing House (Pak-BCH) linked below:

List of Notified IBCs.

Applicants must have qualified personnel with necessary expertise in handling GMOs. Additionally, the laboratory must be well-equipped with appropriate facilities, containment measures, and safety protocols to ensure safe and controlled research activities.

To obtain laboratory permission, applicants must submit a detailed proposal outlining the purpose of the research, the type of genetically modified organisms (GMOs) or materials involved, and the safety measures that will be implemented. Additionally, compliance with Pakistan Biosafety Rules, 2005 (amended 2024). 

 Laboratory permission is valid for a period of two years. 

Yes, the laboratory must comply with Chapter 2 and Chapter 10 of the National Biosafety Guidelines, 2005 (amended 2024).

Yes, reports on the progress of the research, compliance with safety protocols, and irrespective of success must be submitted to the Pak-EPA.

The proponent must have obtained prior laboratory permission, followed by field trial permission, and must have provided biosafety relevant data and compliance reports mentioned in the field trial license.

The commercialization license is valid for a period of two (02) years, subject to renewal.

All seed packs must be properly labeled with "GMOs" the pack size (quantity of seed), and the percentage of germination. This labeling must be completed before the seeds are made available for sale.

Applicants must develop an Emergency Management Plan approved by the Institutional Biosafety Committee (IBC) to address any unintentional release. Additionally, they are responsible for handling seeds in a way that prevents the mixing of transgenic seeds with non-regulated material and ensures no transboundary unintentional release occurs.